## Protocol Section
### Identification Module
**NCT ID:** NCT00617279

**Acronym:** PRODIGY

**Brief Title:** GORE PROPATEN Vascular Graft vs. Disadvantaged Autologous Vein Graft

**Official Title:** Comparison of Primary Patency Between GORE PROPATEN Vascular Graft and Disadvantaged Autologous Vein Graft For Below-Knee Arterial Bypass (PRODIGY Study)

#### Organization Study ID Info
**ID:** PPT 07-05
#### Organization
**Class:** INDUSTRY
**Full Name:** W.L.Gore & Associates
### Status Module
#### Completion Date
**Date:** 2010-02

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-01-12

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-12-08

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2010-02

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2012-01-12

**Type:** ESTIMATED

**Results First Submit Date:** 2011-02-07

**Results First Submit QC Date:** 2011-12-08

#### Start Date
**Date:** 2007-12

**Status Verified Date:** 2011-12

#### Study First Post Date
**Date:** 2008-02-18
**Type:** ESTIMATED
**Study First Submit Date:** 2007-12-18
**Study First Submit QC Date:** 2008-02-05
**Why Stopped:** Study terminated due to low enrollment
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** W.L.Gore & Associates

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The primary patency of the GORE PROPATEN Vascular Graft is equivalent to or better than disadvantaged autologous vein graft in an infragenicular peripheral bypass application at 12 months.

**Detailed Description:** Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow. A disadvantaged autologous vein is defined as meeting at least one of the two following criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator; (2) Usable ipsilateral or contralateral autologous greater saphenous vein that meets any of the following criteria: (a) Diameter of less than or equal to 3.0 mm; (b) Inadequate length requiring splicing; (c) Poor quality vein that is either sclerotic or phlebitic.

### Conditions Module

**Conditions:**

- Peripheral Arterial Occlusive Disease

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 31

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Device: GORE PROPATEN Vascular Graft

**Label:** GORE PROPATEN Vascular Graft:

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Procedure: Disadvantaged Autologous Vein Graft

**Label:** Disadvantaged Autologous Vein Graft

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- GORE PROPATEN Vascular Graft:

**Description:** Arterial Occlusion Bypass

**Name:** GORE PROPATEN Vascular Graft

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Disadvantaged Autologous Vein Graft

**Description:** Arterial Occlusion Bypass

**Name:** Disadvantaged Autologous Vein Graft

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.

**Measure:** Number of Patients With Primary Patency at 12 Months Post-procedure

**Time Frame:** 12 months

**Description:** The number of Major Adverse Event occurrences through one month post-procedure. A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death. This outcome measure presents the number of Major Adverse Event occurrences (i.e. - one patient could have multiple occurrences), and differs from the Serious Adverse Events reporting measure, which presents the number of patients that have been affected by a Serious Adverse Event.

**Measure:** Major Adverse Event Occurrences Through One Month Post-procedure

**Time Frame:** one month post-index procedure

#### Secondary Outcomes

**Description:** Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.

**Measure:** Number of Patients With Primary Patency at One Month Post-procedure

**Time Frame:** One month

**Description:** Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.

**Measure:** Number of Patients With Primary Patency at 6 Months Post-procedure

**Time Frame:** 6 months

**Description:** Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion. The number of patients analyzed at 1 month post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 1 month follow-up visit (or failed to attend their 1 month visit) prior to the termination of the study.

**Measure:** Number of Patients With Assisted Primary Patency at One Month Post-procedure

**Time Frame:** One month

**Description:** Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion.

**Measure:** Number of Patients With Assisted Primary Patency at 6 Months Post-procedure

**Time Frame:** 6 months

**Description:** Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion.

**Measure:** Number of Patients With Assisted Primary Patency at 12 Months Post-procedure

**Time Frame:** 12 months

**Description:** Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.

**Measure:** Number of Patients With Secondary Patency at One Month

**Time Frame:** One month

**Description:** Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.

**Measure:** Number of Patients With Secondary Patency at 6 Months

**Time Frame:** 6 months

**Description:** Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.

**Measure:** Number of Patients With Secondary Patency at 12 Months

**Time Frame:** 12 months

**Description:** Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.

**Measure:** Number of Patients With Limb Salvage (no Major Amputations) at One Month Post-procedure

**Time Frame:** One month

**Description:** Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.

**Measure:** Number of Patients With Limb Salvage (no Major Amputations) at 6 Months Post-procedure

**Time Frame:** 6 months

**Description:** Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.

**Measure:** Number of Patients With Limb Salvage (no Major Amputations) at 12 Months Post-procedure

**Time Frame:** 12 months

**Description:** A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death.

**Measure:** Patients Experiencing Major Adverse Events Through 6 Months Post-procedure

**Time Frame:** 6 months

**Description:** A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death.

**Measure:** Patients Experiencing Major Adverse Events Through 12 Months Post-procedure

**Time Frame:** 12 months

**Measure:** Number of Patients Surviving at One Month

**Time Frame:** One month

**Measure:** Number of Patients Surviving at 6 Months

**Time Frame:** 6 months

**Measure:** Number of Patients Surviving at 12 Months

**Time Frame:** 12 months

**Description:** Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.

**Measure:** Number of Patients With Wound/Graft Infection Through One Month Post-procedure

**Time Frame:** One month

**Description:** Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.

**Measure:** Number of Patients With Wound/Graft Infection Through 6 Months

**Time Frame:** 6 months

**Description:** Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.

**Measure:** Number of Patients With Wound/Graft Infection Through 12 Months

**Time Frame:** 12 months

**Description:** Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.

**Measure:** Number of Patients With Delayed Wound Healing Through One Month Post-procedure

**Time Frame:** One month

**Description:** Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.

**Measure:** Number of Patients With Delayed Wound Healing Through 6 Months Post-procedure

**Time Frame:** 6 months

**Description:** Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.

**Measure:** Number of Patients With Delayed Wound Healing Through 12 Months Post-procedure

**Time Frame:** 12 months

**Description:** The SF-36v2 Health Survey asks 36 questions to measure health and well-being from the patient's point of view. The responses to these questions can be presented as physical component summary and mental component summary scores. An increase in score from baseline indicates an improvement in the patient's condition and a decrease in score from baseline indicates a decline in the patient's condition. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10.

**Measure:** Change in Quality of Life as Evaluated by the SF-36v2® Health Survey From Baseline Through One Month Post-procedure

**Time Frame:** One month

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Patient requires below-knee bypass secondary to severe claudication, rest pain or tissue loss due to peripheral arterial occlusive disease.
2. Patient meets the disadvantaged autologous vein criteria described in Section 4.1.
3. Patient has a post-operative life expectancy greater than one year.
4. Patient is at least 21 years of age.
5. Patient is able to comply with all study requirements and be available for follow-up visits at 1, 6, 12, 24 and 36-months post-procedure.
6. Patient is willing and able to provide written, informed consent.

Exclusion Criteria:

1. Patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known hypersensitivity to heparin.
2. Patient requires an infragenicular bypass for reasons other than peripheral arterial occlusive disease.
3. Patient requires sequential extremity revascularizations or other procedures that require use of additional vascular grafts.
4. Patient is in need of, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure within 30 days of study procedure. However, inflow procedures that facilitate the bypass are permitted, as long as they are not performed at the same sitting as the bypass procedure.
5. Patient has been previously randomized for this study.
6. Patient has active infection in the region of graft placement.

**Minimum Age:** 21 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Birmingham

**Country:** United States

**Facility:** University Of Alabama Medical Center

**State:** Alabama

**Zip:** 35294

**Location 2:**

**City:** Washington

**Country:** United States

**Facility:** Georgetown University Hospital

**State:** District of Columbia

**Zip:** 20007

**Location 3:**

**City:** Atlanta

**Country:** United States

**Facility:** Emory University School of Medicine

**State:** Georgia

**Zip:** 30322

**Location 4:**

**City:** Macon

**Country:** United States

**Facility:** Medical Center of Central Georgia

**State:** Georgia

**Zip:** 31201

**Location 5:**

**City:** Chicago

**Country:** United States

**Facility:** University of Chicago

**State:** Illinois

**Zip:** 60637

**Location 6:**

**City:** Baton Rouge

**Country:** United States

**Facility:** Vascular Specialty Associates

**State:** Louisiana

**Zip:** 70809

**Location 7:**

**City:** Baltimore

**Country:** United States

**Facility:** University of Maryland Medical Center

**State:** Maryland

**Zip:** 21201

**Location 8:**

**City:** Boston

**Country:** United States

**Facility:** Brigham and Women's Hospital

**State:** Massachusetts

**Zip:** 02115

**Location 9:**

**City:** Albany

**Country:** United States

**Facility:** Albany Medical Center

**State:** New York

**Zip:** 12208

**Location 10:**

**City:** Bronx

**Country:** United States

**Facility:** Montifiore Medical Center

**State:** New York

**Zip:** 10467

**Location 11:**

**City:** Stony Brook

**Country:** United States

**Facility:** Stonybrook University Medical Center

**State:** New York

**Zip:** 11794

**Location 12:**

**City:** Cleveland

**Country:** United States

**Facility:** Cleveland Clinic

**State:** Ohio

**Zip:** 44195

**Location 13:**

**City:** Greenville

**Country:** United States

**Facility:** Greenville Hospital System

**State:** South Carolina

**Zip:** 29605

**Location 14:**

**City:** Knoxville

**Country:** United States

**Facility:** University of Tennessee medical Center

**State:** Tennessee

**Zip:** 37920

**Location 15:**

**City:** Houston

**Country:** United States

**Facility:** The Methodist Hospital System

**State:** Texas

**Zip:** 77030

**Location 16:**

**City:** San Antonio

**Country:** United States

**Facility:** Peripheral Vascular Associates

**State:** Texas

**Zip:** 78205

**Location 17:**

**City:** Norfolk

**Country:** United States

**Facility:** Sentara Norfolk Hospital

**State:** Virginia

**Zip:** 23507

#### Overall Officials

**Official 1:**

**Affiliation:** Georgetown University Hospital

**Name:** Richard F. Neville, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** W.L.Gore & Associates

**Name:** Jennifer Recknor, Ph.D.

**Role:** STUDY_DIRECTOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: HIGH

- As Found: Arterial Occlusive Disease

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001157

- Term: Arterial Occlusive Diseases

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** GORE PROPATEN Vascular Graft

**Description:** GORE PROPATEN Vascular Graft

**ID:** EG000

**Other Num Affected:** 4

**Other Num at Risk:** 14

**Serious Number Affected:** 4

**Serious Number At Risk:** 14

**Title:** GORE PROPATEN Vascular Graft

**Group ID:** EG001

**Title:** Disadvantaged Autologous Vein Graft

**Description:** Disadvantaged Autologous Vein Graft

**ID:** EG001

**Other Num Affected:** 3

**Other Num at Risk:** 17

**Serious Number Affected:** 2

**Serious Number At Risk:** 17

**Title:** Disadvantaged Autologous Vein Graft

**Frequency Threshold:** 5

#### Other Events

**Term:** Cellulitis of leg

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MEDra Version 13.1

**Term:** Claudication

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MEDra Version 13.1

**Term:** Edema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MEDra Version 13.1

**Term:** Incision site erythema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MEDra Version 13.1

**Term:** Incision site hematoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MEDra Version 13.1

**Term:** Intraoperative bleeding

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MEDra Version 13.1

**Term:** Myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MEDra Version 13.1

**Term:** Post procedural swelling

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MEDra Version 13.1

**Term:** Sepsis NOS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MEDra Version 13.1

**Term:** Wound dehiscence

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MEDra Version 13.1

**Term:** Wound healing delayed

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** MEDra Version 13.1

#### Serious Events

**Term:** Below knee amputation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA Version 13.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 14

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 17

**Term:** Cerebral infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA Version 13.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 14

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 17

**Term:** Esophageal tear

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 13.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 14

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 17

**Term:** Foot amputation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA Version 13.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 14

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 17

**Term:** Graft infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA Version 13.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 14

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 17

**Term:** Myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA Version 13.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 14

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 17

**Term:** Postoperative wound infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 13.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 14

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 17

**Num Events:** 2

**Term:** Transmetatarsal amputation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA Version 13.1

##### Stats

**Group ID:** EG000

**Num At Risk:** 14

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 17

**Num Events:** 1

**Term:** Vascular graft occlusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Injury, poisoning and procedural complications

**Source Vocabulary:** MedDRA Version 13.1

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 14

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 17

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 14

**Group ID:** BG001

**Value:** 17

**Group ID:** BG002

**Value:** 31

**Units:** Participants

### Group

**ID:** BG000

**Title:** GORE PROPATEN Vascular Graft:

**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.

### Group

**ID:** BG001

**Title:** Disadvantaged Autologous Vein Graft

**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 14

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 10

#### Measurement

**Group ID:** BG002

**Value:** 17

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 10

**Value:** 65

#### Measurement

**Group ID:** BG001

**Spread:** 8

**Value:** 68

#### Measurement

**Group ID:** BG002

**Spread:** 9

**Value:** 67

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 12

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 7

#### Measurement

**Group ID:** BG001

**Value:** 12

#### Measurement

**Group ID:** BG002

**Value:** 19

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 14

#### Measurement

**Group ID:** BG001

**Value:** 17

#### Measurement

**Group ID:** BG002

**Value:** 31

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** LTE60
**Restrictive Agreement:** True
### Limitations and Caveats
**Description:** The study was terminated prior to completion of enrollment. The primary patency and secondary endpoints were not calculated due to the paucity of data.
### Point of Contact
**Email:** cbadorek@wlgore.com
**Organization:** W. L. Gore & Associates, Inc.
**Phone:** 928.864.3486
**Title:** Chad Badorek, Clinical Study Manager
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
### Outcome Measure 13
### Outcome Measure 14
### Outcome Measure 15
### Outcome Measure 16
### Outcome Measure 17
### Outcome Measure 18
### Outcome Measure 19
### Outcome Measure 20
### Outcome Measure 21
### Outcome Measure 22
### Outcome Measure 23
### Outcome Measure 24
### Outcome Measure 25
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
**Title:** 
#### Outcome Measure 15
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 10
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
**Title:** 
#### Outcome Measure 16
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 17
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
#### Outcome Measure 18
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 15
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
**Title:** 
#### Outcome Measure 19
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16
**Title:** 
#### Outcome Measure 20
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16
**Title:** 
#### Outcome Measure 21
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 2
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 12
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16
**Title:** 
#### Outcome Measure 22
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 14
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16
**Title:** 
#### Outcome Measure 23
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16
**Title:** 
#### Outcome Measure 24
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 13
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 16
**Title:** 
#### Outcome Measure 25
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6.61
- **Upper Limit:** 
- **Value:** 2.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 8.77
- **Upper Limit:** 
- **Value:** 2.2
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 8.67
- **Upper Limit:** 
- **Value:** -3.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 10.44
- **Upper Limit:** 
- **Value:** 4.4
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.
**Parameter Type:** NUMBER
**Population Description:** The number of patients analyzed at 12 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that many enrolled patients did not have their 12 month follow-up visit prior to the termination of the study.
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Number of Patients With Primary Patency at 12 Months Post-procedure
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** OG000
**Title:** GORE PROPATEN Vascular Graft:
##### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** OG001
**Title:** Disadvantaged Autologous Vein Graft
#### Outcome Measure 2
**Description:** Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.
**Parameter Type:** NUMBER
**Population Description:** The number of patients analyzed at 1 month post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 1 month follow-up visit (or failed to attend their 1 month visit) prior to the termination of the study.
**Reporting Status:** POSTED
**Time Frame:** One month
**Title:** Number of Patients With Primary Patency at One Month Post-procedure
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** OG000
**Title:** GORE PROPATEN Vascular Graft:
##### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** OG001
**Title:** Disadvantaged Autologous Vein Graft
#### Outcome Measure 3
**Description:** The number of Major Adverse Event occurrences through one month post-procedure. A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death. This outcome measure presents the number of Major Adverse Event occurrences (i.e. - one patient could have multiple occurrences), and differs from the Serious Adverse Events reporting measure, which presents the number of patients that have been affected by a Serious Adverse Event.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** one month post-index procedure
**Title:** Major Adverse Event Occurrences Through One Month Post-procedure
**Type:** PRIMARY
**Unit of Measure:** Events
##### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** OG000
**Title:** GORE PROPATEN Vascular Graft:
##### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** OG001
**Title:** Disadvantaged Autologous Vein Graft
#### Outcome Measure 4
**Description:** Primary patency is defined as hemodynamic evidence of blood flow through an open graft that has maintained uninterrupted patency and has not previously undergone a revision to restore blood flow.
**Parameter Type:** NUMBER
**Population Description:** The number of patients analyzed at 6 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 6 month follow-up visit (or failed to attend their 6 month visit) prior to the termination of the study.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Number of Patients With Primary Patency at 6 Months Post-procedure
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** OG000
**Title:** GORE PROPATEN Vascular Graft:
##### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** OG001
**Title:** Disadvantaged Autologous Vein Graft
#### Outcome Measure 5
**Description:** Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion. The number of patients analyzed at 1 month post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 1 month follow-up visit (or failed to attend their 1 month visit) prior to the termination of the study.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** One month
**Title:** Number of Patients With Assisted Primary Patency at One Month Post-procedure
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** OG000
**Title:** GORE PROPATEN Vascular Graft:
##### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** OG001
**Title:** Disadvantaged Autologous Vein Graft
#### Outcome Measure 6
**Description:** Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion.
**Parameter Type:** NUMBER
**Population Description:** The number of patients analyzed at 6 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 6 month follow-up visit (or failed to attend their 6 month visit) prior to the termination of the study.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Number of Patients With Assisted Primary Patency at 6 Months Post-procedure
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** OG000
**Title:** GORE PROPATEN Vascular Graft:
##### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** OG001
**Title:** Disadvantaged Autologous Vein Graft
#### Outcome Measure 7
**Description:** Assisted primary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) within the graft to restore blood flow prior to occlusion.
**Parameter Type:** NUMBER
**Population Description:** The number of patients analyzed at 12 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 12 month follow-up visit (or failed to attend their 12 month visit) prior to the termination of the study.
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Number of Patients With Assisted Primary Patency at 12 Months Post-procedure
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** OG000
**Title:** GORE PROPATEN Vascular Graft:
##### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** OG001
**Title:** Disadvantaged Autologous Vein Graft
#### Outcome Measure 8
**Description:** Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.
**Parameter Type:** NUMBER
**Population Description:** The number of patients analyzed at 1 month post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 1 month follow-up visit (or failed to attend their 1 month visit) prior to the termination of the study.
**Reporting Status:** POSTED
**Time Frame:** One month
**Title:** Number of Patients With Secondary Patency at One Month
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** OG000
**Title:** GORE PROPATEN Vascular Graft:
##### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** OG001
**Title:** Disadvantaged Autologous Vein Graft
#### Outcome Measure 9
**Description:** Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.
**Parameter Type:** NUMBER
**Population Description:** The number of patients analyzed at 6 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 6 month follow-up visit (or failed to attend their 6 month visit) prior to the termination of the study.
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Number of Patients With Secondary Patency at 6 Months
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** OG000
**Title:** GORE PROPATEN Vascular Graft:
##### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** OG001
**Title:** Disadvantaged Autologous Vein Graft
#### Outcome Measure 10
**Description:** Secondary patency is defined as hemodynamic evidence of blood flow through an open graft that has previously undergone revision(s) to restore blood flow after occlusion.
**Parameter Type:** NUMBER
**Population Description:** The number of patients analyzed at 12 months post-procedure does not equal the number of patients originally enrolled into the study. This is due to the fact that a number of enrolled patients did not have their 12 month follow-up visit (or failed to attend their 12 month visit) prior to the termination of the study.
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Number of Patients With Secondary Patency at 12 Months
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** OG000
**Title:** GORE PROPATEN Vascular Graft:
##### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** OG001
**Title:** Disadvantaged Autologous Vein Graft
#### Outcome Measure 11
**Description:** Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** One month
**Title:** Number of Patients With Limb Salvage (no Major Amputations) at One Month Post-procedure
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** OG000
**Title:** GORE PROPATEN Vascular Graft:
##### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** OG001
**Title:** Disadvantaged Autologous Vein Graft
#### Outcome Measure 12
**Description:** Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Number of Patients With Limb Salvage (no Major Amputations) at 6 Months Post-procedure
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** OG000
**Title:** GORE PROPATEN Vascular Graft:
##### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** OG001
**Title:** Disadvantaged Autologous Vein Graft
#### Outcome Measure 13
**Description:** Limb salvage is defined as relief from symptoms sufficient to prevent major amputation. An amputation is considered to be major when there is surgical removal of a portion of the study leg that would preclude standing and walking without a prosthesis.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Number of Patients With Limb Salvage (no Major Amputations) at 12 Months Post-procedure
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** OG000
**Title:** GORE PROPATEN Vascular Graft:
##### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** OG001
**Title:** Disadvantaged Autologous Vein Graft
#### Outcome Measure 14
**Description:** A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Patients Experiencing Major Adverse Events Through 6 Months Post-procedure
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** OG000
**Title:** GORE PROPATEN Vascular Graft:
##### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** OG001
**Title:** Disadvantaged Autologous Vein Graft
#### Outcome Measure 15
**Description:** A major adverse event requires significant therapy, including unplanned increase in the level of care, permanent sequelae, hospitalization, or death.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Patients Experiencing Major Adverse Events Through 12 Months Post-procedure
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** OG000
**Title:** GORE PROPATEN Vascular Graft:
##### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** OG001
**Title:** Disadvantaged Autologous Vein Graft
#### Outcome Measure 16
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** One month
**Title:** Number of Patients Surviving at One Month
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** OG000
**Title:** GORE PROPATEN Vascular Graft:
##### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** OG001
**Title:** Disadvantaged Autologous Vein Graft
#### Outcome Measure 17
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Number of Patients Surviving at 6 Months
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** OG000
**Title:** GORE PROPATEN Vascular Graft:
##### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** OG001
**Title:** Disadvantaged Autologous Vein Graft
#### Outcome Measure 18
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Number of Patients Surviving at 12 Months
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** OG000
**Title:** GORE PROPATEN Vascular Graft:
##### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** OG001
**Title:** Disadvantaged Autologous Vein Graft
#### Outcome Measure 19
**Description:** Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** One month
**Title:** Number of Patients With Wound/Graft Infection Through One Month Post-procedure
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** OG000
**Title:** GORE PROPATEN Vascular Graft:
##### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** OG001
**Title:** Disadvantaged Autologous Vein Graft
#### Outcome Measure 20
**Description:** Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Number of Patients With Wound/Graft Infection Through 6 Months
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** OG000
**Title:** GORE PROPATEN Vascular Graft:
##### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** OG001
**Title:** Disadvantaged Autologous Vein Graft
#### Outcome Measure 21
**Description:** Wound/graft infection was not specifically defined in the protocol and was left to the Investigator's standard of care.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Number of Patients With Wound/Graft Infection Through 12 Months
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** OG000
**Title:** GORE PROPATEN Vascular Graft:
##### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** OG001
**Title:** Disadvantaged Autologous Vein Graft
#### Outcome Measure 22
**Description:** Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** One month
**Title:** Number of Patients With Delayed Wound Healing Through One Month Post-procedure
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** OG000
**Title:** GORE PROPATEN Vascular Graft:
##### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** OG001
**Title:** Disadvantaged Autologous Vein Graft
#### Outcome Measure 23
**Description:** Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Number of Patients With Delayed Wound Healing Through 6 Months Post-procedure
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** OG000
**Title:** GORE PROPATEN Vascular Graft:
##### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** OG001
**Title:** Disadvantaged Autologous Vein Graft
#### Outcome Measure 24
**Description:** Delayed wound healing was not specifically defined in the protocol and was left to the Investigator's standard of care.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 12 months
**Title:** Number of Patients With Delayed Wound Healing Through 12 Months Post-procedure
**Type:** SECONDARY
**Unit of Measure:** Participants
##### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** OG000
**Title:** GORE PROPATEN Vascular Graft:
##### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** OG001
**Title:** Disadvantaged Autologous Vein Graft
#### Outcome Measure 25
**Description:** The SF-36v2 Health Survey asks 36 questions to measure health and well-being from the patient's point of view. The responses to these questions can be presented as physical component summary and mental component summary scores. An increase in score from baseline indicates an improvement in the patient's condition and a decrease in score from baseline indicates a decline in the patient's condition. The subscale and total score ranges from 0 to 100 but is normalized so that a score of 50 is the population mean, with a standard deviation of 10.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The number of patients analyzed at 1 month does not equal the number of patients originally enrolled into the study, due to the fact that a number of enrolled patients did not have (or failed to attend) their 1 month follow-up visit prior to the termination of the study.
**Reporting Status:** POSTED
**Time Frame:** One month
**Title:** Change in Quality of Life as Evaluated by the SF-36v2® Health Survey From Baseline Through One Month Post-procedure
**Type:** SECONDARY
**Unit of Measure:** scores on a scale
##### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** OG000
**Title:** GORE PROPATEN Vascular Graft:
##### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** OG001
**Title:** Disadvantaged Autologous Vein Graft
### Participant Flow Module
#### Group
**Description:** Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
**ID:** FG000
**Title:** GORE PROPATEN Vascular Graft:
#### Group
**Description:** Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
**ID:** FG001
**Title:** Disadvantaged Autologous Vein Graft
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Study terminated by Sponsor
###### Reason
**Group ID:** FG000
**Number of Subjects:** 10
###### Reason
**Group ID:** FG001
**Number of Subjects:** 15
##### Withdraw
**Type:** Graft abandonment
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 14
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 17
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 0
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 0
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 14
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 17
**Recruitment Details:** Patients requiring below-knee bypass secondary to severe claudication, rest pain or tissue loss due to peripheral arterial occlusive disease were recruited. Recruitment commenced December 2007 and was terminated by the Sponsor January 2010 due to slow enrollment. Investigative site locations included university hospitals and other medical clinics.
**Has Results:** True