## Protocol Section
### Identification Module
**NCT ID:** NCT00916279

**Acronym:** PERVIDEO I

**Brief Title:** PERVIDEO I Registry, The Lutonix Paclitaxel-Coated Balloon Catheter for the Treatment of Coronary In-Stent Restenosis

**Official Title:** A Prospective, Multicenter, European Registry Investigating the Lutonix Paclitaxel-Coated Balloon for the Treatment of In-Stent Restenosis Within Bare-Metal Stents

#### Organization Study ID Info
**ID:** CL0010-01
#### Organization
**Class:** INDUSTRY
**Full Name:** C. R. Bard
### Status Module
#### Completion Date
**Date:** 2011-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-02-27

**Type:** ACTUAL

**Last Update Submit Date:** 2017-01-12

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-10

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2015-12-21

**Type:** ESTIMATED

**Results First Submit Date:** 2014-08-05

**Results First Submit QC Date:** 2015-11-17

#### Start Date
**Date:** 2009-06

**Status Verified Date:** 2017-01

#### Study First Post Date
**Date:** 2009-06-09
**Type:** ESTIMATED
**Study First Submit Date:** 2009-06-04
**Study First Submit QC Date:** 2009-06-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** C. R. Bard

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The study will enroll patients with angiographic evidence of in-stent restenosis of a previously placed bare-metal stent. Subjects will be treated with a Lutonix Catheter. The purpose is to investigate the feasibility, safety, and efficacy of the Lutonix Catheter in the native coronary system. Angiographic and clinical outcomes will be assessed.

### Conditions Module

**Conditions:**

- In-Stent Restenosis

**Keywords:**

- Bare Metal In-Stent Restenosis

- Paclitaxel Coated Balloon Catheter

- Drug Coated Balloon

- Coronary Artery Disease

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 41

**Type:** ACTUAL

**Phases:**

- PHASE1

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Device: Lutonix Paclitaxel-Coated Balloon

**Label:** Lutonix Catheter

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Lutonix Catheter

**Description:** PTCA

**Name:** Lutonix Paclitaxel-Coated Balloon

**Other Names:**

- Drug Coated Balloon

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** Percent Diameter Stenosis (%DS) in the Analysis Segment

**Time Frame:** 6 months

**Description:** Paired change in percent diameter stenosis (%DS) in the analysis segment from post-procedure through 6 months. I.e., %DS at follow-up less %DS post procedure per patient.

**Measure:** Change in Diameter Stenosis (%DS) From Post-procedure Through 6 Months

**Time Frame:** 6 Months

#### Secondary Outcomes

**Description:** Change in (loss of) lumen diameter from baseline through 6 months in the analysis segment (including the treated segment and 5mm proximal and distal).

**Measure:** Late Lumen Loss

**Time Frame:** 6 months

**Description:** Major adverse coronary events (MACE), including the composite of cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR).

**Measure:** MACE Rate

**Time Frame:** 30 Days

**Description:** Subjects with percent diameter stenosis \>50% in the analysis segment.

**Measure:** Binary Restenosis

**Time Frame:** 6 Months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Male or non-pregnant/non-breast feeding Female ≥18 Years of age. Women of childbearing potential must have a negative pregnancy test within 7 days of the procedure;
* Documented stable angina pectoris Canadian Cardiovascular Society Classification (CCSC) 1-4, unstable angina pectoris with documented ischemia (Braunwald I-II) or documented silent ischemia;
* Previous history of native coronary bare metal stenting ≥60 days;
* LVEF ≥25%;
* Patient is an acceptable candidate for PTCA, stenting, and emergent CABG;
* Patient is willing to provide informed consent and comply with follow-up visits and testing schedule;
* Target lesion is in a native coronary with previous single bare metal stent; Stenosis is ≥50% and \<100% by visual estimate or QCA prior to defined pre-dilatation;
* Reference Vessel Diameter (RVD) is ≥2.5 and ≤3.25;
* Target lesion is ≤40 mm in length and can be treated in its entirety by no more than 2 contiguous Lutonix Catheters;
* Guidewire is able to cross lesion(s) and be placed in distal vessel prior to enrollment;
* Enrollment permitted after successful treatment of 1 to 2 non-study lesions in a single other non-study vessel. Successful treatment is defined as ≤30% residual stenosis with TIMI III flow and no evidence of dissection.

Exclusion Criteria:

* History of Stroke within past 6 months;
* History of MI or thrombolysis within 72 hours of randomization;
* History of previous target vessel perforation;
* Prior vascular brachytherapy;
* Angiographic evidence of thrombus or dissection within the target vessel;
* Intervention of another coronary lesion \<60 days before index procedure day or planned following index procedure;
* Target lesion is in the Left Main or vessel ostium and has excessive calcification or tortuosity or involves bifurcation disease of vessel ≥2.5 mm;
* Target lesion is planned to be treated with something other than PTCA (i.e. stent, cutting balloon, atherectomy, VBT, etc.);
* Uncontrollable allergies to procedure medications, materials, or contrast;
* Patient has previous stent procedure with any drug-coated or drug eluting stent device in the target coronary vessel;
* Known sensitivity to paclitaxel or other antimitogenic agent;
* Patient has a stent sandwich (a stench previously deployed within another stent;
* Pre-procedure CKMB \>2x ULN or positive Troponin;
* Creatinine \>2.0 mg/dl;
* Leukocyte \<3500/mL;
* Platelet \<100,000 mL or \>750,000 mL;
* Currently taking or must resume warfarin;
* Patient is contraindicated for anti-platelet therapy or it will need to be withdrawn for a planned procedure;
* The patient is currently participating in another investigational drug or device study that has not completed its primary endpoint or that clinically interferes with the endpoints of this study;

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Aalst

**Country:** Belgium

**Facility:** Onze Lieve Vrouw Ziekenhuis

**Zip:** 9300

**Location 2:**

**City:** Bad Nauheim

**Country:** Germany

**Facility:** Kerckhoff Klinik

**Zip:** 61231

**Location 3:**

**City:** Essen

**Country:** Germany

**Facility:** Westdeutsches Herzzentrum Essen

**Location 4:**

**City:** Hamburg

**Country:** Germany

**Facility:** Alte Clinic Center for Cardiology

**Zip:** 22527

**Location 5:**

**City:** Leipzig

**Country:** Germany

**Facility:** Herzzentrum Leipzig GmbH

**Location 6:**

**City:** Amsterdam

**Country:** Netherlands

**Facility:** Academic Medical Center

**Location 7:**

**City:** Eindhoven

**Country:** Netherlands

**Facility:** Catherina Ziekenhuis

**Location 8:**

**City:** Nieuwegein

**Country:** Netherlands

**Facility:** Sint Antonius Ziehenhuis

#### Overall Officials

**Official 1:**

**Affiliation:** Brigham & Women's Hospital, Boston, MA

**Name:** Laura Mauri, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004 Aug 17;110(7):810-4. doi: 10.1161/01.CIR.0000138929.71660.E0. Epub 2004 Aug 9.

**PMID:** 15302790

**Citation:** Speck U, Scheller B, Abramjuk C, Breitwieser C, Dobberstein J, Boehm M, Hamm B. Neointima inhibition: comparison of effectiveness of non-stent-based local drug delivery and a drug-eluting stent in porcine coronary arteries. Radiology. 2006 Aug;240(2):411-8. doi: 10.1148/radiol.2402051248.

**PMID:** 16864669

**Citation:** Stone GW, Ellis SG, O'Shaughnessy CD, Martin SL, Satler L, McGarry T, Turco MA, Kereiakes DJ, Kelley L, Popma JJ, Russell ME; TAXUS V ISR Investigators. Paclitaxel-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the TAXUS V ISR randomized trial. JAMA. 2006 Mar 15;295(11):1253-63. doi: 10.1001/jama.295.11.1253. Epub 2006 Mar 12.

**PMID:** 16531618

**Citation:** Scheller B, Hehrlein C, Bocksch W, Rutsch W, Haghi D, Dietz U, Bohm M, Speck U. Treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter. N Engl J Med. 2006 Nov 16;355(20):2113-24. doi: 10.1056/NEJMoa061254. Epub 2006 Nov 13.

**PMID:** 17101615

**Citation:** Holmes DR Jr, Teirstein P, Satler L, Sketch M, O'Malley J, Popma JJ, Kuntz RE, Fitzgerald PJ, Wang H, Caramanica E, Cohen SA; SISR Investigators. Sirolimus-eluting stents vs vascular brachytherapy for in-stent restenosis within bare-metal stents: the SISR randomized trial. JAMA. 2006 Mar 15;295(11):1264-73. doi: 10.1001/jama.295.11.1264. Epub 2006 Mar 12.

**PMID:** 16531619

**Citation:** Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, et al. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. N Engl J Med. 1994 Aug 25;331(8):489-95. doi: 10.1056/NEJM199408253310801.

**PMID:** 8041413

**Citation:** Kastrati A, Mehilli J, von Beckerath N, Dibra A, Hausleiter J, Pache J, Schuhlen H, Schmitt C, Dirschinger J, Schomig A; ISAR-DESIRE Study Investigators. Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial. JAMA. 2005 Jan 12;293(2):165-71. doi: 10.1001/jama.293.2.165.

**PMID:** 15644543

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6549

- Name: Coronary Disease

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: LOW

- As Found: Unknown

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000000972

- Term: Antineoplastic Agents, Phytogenic

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000050257

- Term: Tubulin Modulators

- ID: D000050256

- Term: Antimitotic Agents

- ID: D000050258

- Term: Mitosis Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M19537

- Name: Paclitaxel

- Relevance: HIGH

- As Found: Surgery

- ID: M231

- Name: Albumin-Bound Paclitaxel

- Relevance: LOW

- As Found: Unknown

- ID: M26197

- Name: Tubulin Modulators

- Relevance: LOW

- As Found: Unknown

- ID: M26196

- Name: Antimitotic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000017239

- Term: Paclitaxel

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Lutonix Catheter

**Description:** Lutonix Paclitaxel-Coated Balloon: PTCA

**ID:** EG000

**Other Num Affected:** 15

**Other Num at Risk:** 41

**Serious Number Affected:** 22

**Serious Number At Risk:** 41

**Title:** Lutonix Catheter

**Frequency Threshold:** 5

#### Other Events

**Term:** Angina

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** 

**Term:** Chest Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Dyspnea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** 

**Term:** Palpitations

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** 

**Term:** Thoracic Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

#### Serious Events

**Term:** Death of unknown cause

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** Abdominal aortic aneurysm

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** Acute renal failure post-interventional

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** Rotoblation of non-target vessel/fell into lung edema & ventricular fibrillation. Resulted in death

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** Aneurysm spurium of RCA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** Aneurysma rupture by distal endoleak right iliacal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** Angina

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 6

**Num At Risk:** 41

**Num Events:** 8

**Term:** Bacteria MIC = staphylococcus auras

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** Cardiac decomposition with pneumonia and sepsis and respiratory insufficiency due to pulmonary edema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** CCSIII caused angio. Occlusion of prox. RCA NTVR done

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** Effective reconstruction: RCA - 3 DES stents (atypical chest pain / discomfort, angiographic stenosi

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** Hospitalization

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 41

**Num Events:** 2

**Term:** Hypertensive Crisis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** Instent Restenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 41

**Num Events:** 2

**Term:** Kidney Stones

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** Nasal bleeding / epistaxis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** Dyspnea and Thorax Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** Pericardial abscess

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** Perimyocarditis with pericardial effusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 41

**Num Events:** 2

**Term:** Pulmonary edema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** Progression of coronary artery disease proximal to treated lesion (non-TLR-PCI)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** Recurrent Depressive disorder, pre-existing condition

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** Reintervention

**Assessment Type:** SYSTEMATIC_ASSESSMENT

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** Re-PCI

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 41

**Num Events:** 2

**Term:** Respiratory insufficiency

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** Sepsis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 1

**Term:** Stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 41

**Num Events:** 5

**Term:** Thoracic pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 41

**Num Events:** 2

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 41

**Units:** Participants

### Group

**ID:** BG000

**Title:** Lutonix Catheter

**Description:** Lutonix Paclitaxel-Coated Balloon: PTCA

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 14

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

#### Measurement

**Group ID:** BG000

**Value:** 27

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 11.0

**Value:** 64.4

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 10

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 31

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

**Class Title:** Belgium

#### Measurement

**Group ID:** BG000

**Value:** 4

**Class Title:** Netherlands

#### Measurement

**Group ID:** BG000

**Value:** 36

**Class Title:** Germany

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 17

**Class Title:** CFX

#### Measurement

**Group ID:** BG000

**Value:** 13

**Class Title:** LAD

#### Measurement

**Group ID:** BG000

**Value:** 11

**Class Title:** RCA

**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:** Gender
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 5
**Description:** Target coronary vessel(s) treated: circumflex (CFX), left anterior descending (LAD), right coronary artery (RCA).
**Parameter Type:** NUMBER
**Title:** Target Lesion Location
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** LutonixResearch@crbard.com
**Organization:** Lutonix Inc. a subsidiary of C.R. Bard
**Phone:** 763-445-2352
**Title:** Chris Barry
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 17.6
- **Upper Limit:** 
- **Value:** 36.0
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.39
- **Upper Limit:** 
- **Value:** 0.17
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 16.9
- **Upper Limit:** 
- **Value:** 8.5
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** ITT
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Percent Diameter Stenosis (%DS) in the Analysis Segment
**Type:** PRIMARY
**Unit of Measure:** Percentage stenosis of vessel diameter
##### Group
**Description:** Lutonix paclitaxel-coated PTCA balloon catheter
**ID:** OG000
**Title:** Lutonix DCB Catheter
#### Outcome Measure 2
**Description:** Change in (loss of) lumen diameter from baseline through 6 months in the analysis segment (including the treated segment and 5mm proximal and distal).
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** ITT
**Reporting Status:** POSTED
**Time Frame:** 6 months
**Title:** Late Lumen Loss
**Type:** SECONDARY
**Unit of Measure:** (mm)
##### Group
**Description:** Lutonix Paclitaxel-Coated Balloon: PTCA
**ID:** OG000
**Title:** Lutonix Catheter
#### Outcome Measure 3
**Description:** Major adverse coronary events (MACE), including the composite of cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR).
**Parameter Type:** NUMBER
**Population Description:** ITT
**Reporting Status:** POSTED
**Time Frame:** 30 Days
**Title:** MACE Rate
**Type:** SECONDARY
**Unit of Measure:** Percentage of patients
##### Group
**Description:** Lutonix Paclitaxel-Coated Balloon: PTCA
**ID:** OG000
**Title:** Lutonix PTCA Catheter
#### Outcome Measure 4
**Description:** Paired change in percent diameter stenosis (%DS) in the analysis segment from post-procedure through 6 months. I.e., %DS at follow-up less %DS post procedure per patient.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** ITT
**Reporting Status:** POSTED
**Time Frame:** 6 Months
**Title:** Change in Diameter Stenosis (%DS) From Post-procedure Through 6 Months
**Type:** PRIMARY
**Unit of Measure:** percent diameter stenosis
##### Group
**Description:** Lutonix paclitaxel-coated PTCA balloon catheter
**ID:** OG000
**Title:** Lutonix DCB Catheter
#### Outcome Measure 5
**Description:** Subjects with percent diameter stenosis \>50% in the analysis segment.
**Parameter Type:** NUMBER
**Population Description:** ITT
**Reporting Status:** POSTED
**Time Frame:** 6 Months
**Title:** Binary Restenosis
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Lutonix Paclitaxel-Coated Balloon: PTCA
**ID:** OG000
**Title:** Lutonix DCB Catheter
### Participant Flow Module
#### Group
**Description:** Lutonix Paclitaxel-Coated Balloon: PTCA
**ID:** FG000
**Title:** Lutonix DCB Catheter
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Death
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 41
##### Milestone
**Type:** 30 Days
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 41
##### Milestone
**Type:** 6 Months
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 41
##### Milestone
**Type:** 24 Months
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 37
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 37
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 4
**Recruitment Details:** Enrollment from June 3, 2009 through December 8, 2009 at 7 centers in Germany, Netherlands, and Belgium.
**Has Results:** True