## Protocol Section
### Identification Module
**NCT ID:** NCT03901079

**Brief Title:** Trial for A Novel Facilitated Antegrade Steering Technique in Revascularization of Coronary Chronic Total Occlusions

**Official Title:** A Prospective, Multi-center, Non-Randomized Controled Trial for A Novel Facilitated Antegrade Steering Technique in Revascularization of Coronary Chronic Total Occlusions In Chinese Population--FAST CTO China

#### Organization Study ID Info
**ID:** S2362
#### Organization
**Class:** INDUSTRY
**Full Name:** Boston Scientific Corporation
### Status Module
#### Completion Date
**Date:** 2021-03-24

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-12-08

**Type:** ACTUAL

**Last Update Submit Date:** 2023-12-06

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2020-01-10

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2023-12-08

**Type:** ACTUAL

**Results First Submit Date:** 2021-03-25

**Results First Submit QC Date:** 2023-12-06

#### Start Date
**Date:** 2018-10-08

**Type:** ACTUAL

**Status Verified Date:** 2023-12

#### Study First Post Date
**Date:** 2019-04-03
**Type:** ACTUAL
**Study First Submit Date:** 2018-08-10
**Study First Submit QC Date:** 2019-04-02
**Why Stopped:** HGRAC approval letter had expired. The enrollment speed of FAST CTO is much slower than planning and the scientific value becomes limited due to the delayed data readout anticipation.
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Boston Scientific Corporation

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** To assess the safety and efficacy of the BridgePoint CTO system in recanalization of CTO lesions which are resistant to a conventional wire approach in a multicenter study in Chinese population

**Detailed Description:** All subjects who are candidates for percutaneous coronary intervention (PCI), signed the informed consent form and had chronic total coronary occlusion (CTO) lesion will be evaluated for enrollment in this study.At least 100 subjects will be enrolled. Each site will be allowed to enroll up to a maximum of 25 subjects.

Primary Effectiveness Endpoint:

Technical Success: the ability of the BridgePoint Medical System to successfully facilitate placement of a guidewire beyond a CTO lesion in the true vessel lumen/within the collaterals in those cases that were otherwise refractory to treatment with a currently marketed guidewire

Primary Safety Endpoint:

30-day MACE rate for CTO cases in which the BridgePoint Medical System was used.

MACE is defined as the composite of cardiac death, Q-wave and non-Q-wave myocardial infarction(MI), and any ischemia-driven target lesion revascularization(TLR).

### Conditions Module

**Conditions:**

- CAD

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 20

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** BridgePoint CTO System:

* CrossBoss Catheter
* Stingray LP Catheter
* Stingray Guidewire and Extension Wire

**Intervention Names:**

- Other: single-arm study

**Label:** CTO BridgePoint system

### Interventions

#### Intervention 1

**Arm Group Labels:**

- CTO BridgePoint system

**Description:** single-arm study

**Name:** single-arm study

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 6 subjects have the results data, and 5 of them (83.3%) reported technical success. One (16.7%) failed.

**Measure:** Technical Success: Successfully Facilitate Placement of a Guidewire Beyond a CTO Lesion in the True Vessel Lumen/Within the Collaterals

**Time Frame:** Subject follow up will occur via telephone contact or clinic visit at 30 days,6 and 12 months post index procedure.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Subject must be ≥ 18 but \< 80 years of age
* Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed
* Subject is eligible for percutaneous coronary intervention (PCI)
* Subject has symptomatic coronary artery disease or myocardial infraction (MI) with objective evidence of ischemia or silent ischemia
* Subject is an acceptable candidate for coronary artery bypass grafting (CABG)
* Subject is willing to comply with all protocol-required follow-up evaluation
* Subject has a left ventricular ejection fraction (LVEF) ≥45% as measured within 60 days prior to enrollment

Angiographic Inclusion Criteria:

AI1. A maximum of one de novo CTO lesion in a native coronary artery with thrombolysis in Myocardial Infarction (TIMI) flow grade 0 AI2. Non-acute CTO lesion with an estimated duration of at least 3 months by clinical history and/or comparison with previous angiogram or electrocardiogram(ECG) AI3. The CTO lesion must have an angiographic landing zone≥ 10 mm proximal to any major bifurcation without severe calcification.

AI4. Lesion length \< 40mm without excessive tortuosity and angulation(\>45°)

Exclusion Criteria:

* Subject has clinical symptoms and/or ECG changes consistent with Acute MI (include STEMI and Non- STEMI) within 1 week
* Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable angina
* Subject has received an organ transplant or is on a waiting list for an organ transplant
* Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure
* Planned PCI (including staged procedures) or CABG after the index procedure
* Subject has a known allergy to contrast (that cannot be adequately pre-medicated) and/or protocol-required concomitant medications (e.g., aspirin or all thienopyridines)
* Subject has one of the following (as assessed prior to the index procedure):

Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life expectancy of less than 12 months / Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.) / Planned procedure that may cause non-compliance with the protocol or confound data interpretation

* Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin, coumadin)
* Subject with out of range complete blood count (CBC) values that are determined by the study physician to be clinically significant.
* Subject is on dialysis or has baseline serum creatinine level \>2.0 mg/dL (177µmol/L)
* Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions
* Subject has had a history of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months
* Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding
* Subject has signs or symptoms of active heart failure (i.e., NYHA class IV) or LVEF \< 45% at the time of the index procedure
* Subject is participating in another investigational drug or device clinical trial that has not reached its primary endpoint or intends to participate in another investigational drug or device clinical trial within 12 months after the index procedure
* Subject had PCI within the previous 2 weeks
* Subject with known intention to procreate within 12 months after the index procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure)
* Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)

Angiographic Exclusion Criteria:

AE1. Target lesion is an aorto-ostial lesion or located in left main coronary artery, previous venous or arterial bypass grafts AE2. Target lesion involving a segment of previous stent AE3. Target vessel has excessive tortuosity and/or angulation proximal to the target lesion(\>45°) AE4. Target lesion and/or the target vessel proximal to the target lesion is moderately to severely calcified by visual estimate AE5. Target lesion is located within 5 mm of the origin of the left anterior descending (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate AE6. Target lesion will be accessed via a saphenous vein graft or arterial graft AE7. Subject has unprotected left main coronary artery disease (\>50% diameter stenosis) AE8. Thrombus, or possible thrombus, present in the target vessel (by visual estimate) AE9. Target vessel has a dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** All subjects who are candidates for percutaneous coronary intervention (PCI), signed the informed consent form and had chronic total coronary occlusion (CTO) lesion will be evaluated for enrollment in this study.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Chengdu

**Country:** China

**Facility:** West China Hospital Sichuan University

**State:** Sichuan

**Zip:** 610041

#### Overall Officials

**Official 1:**

**Affiliation:** Fuwai Hospital, CAMS & PUMC

**Name:** Yuejin Yang, Doc.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Document Section

### Large Document Module

#### Large Docs

- Date: 2019-11-12

- Filename: Prot_001.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: False

- Label: Study Protocol

- Size: 689627

- Type Abbrev: Prot

- Upload Date: 2021-03-22T23:08

- Date: 2020-01-20

- Filename: SAP_002.pdf

- Has ICF: False

- Has Protocol: False

- Has SAP: True

- Label: Statistical Analysis Plan

- Size: 377857

- Type Abbrev: SAP

- Upload Date: 2022-03-01T01:20

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: Rare

- Name: Rare Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** CTO BridgePoint System

**Deaths Num At Risk:** 20

**Description:** BridgePoint CTO System:

* CrossBoss Catheter
* Stingray LP Catheter
* Stingray Guidewire and Extension Wire

single-arm study: single-arm study

**ID:** EG000

**Other Num at Risk:** 20

**Serious Number Affected:** 4

**Serious Number At Risk:** 20

**Title:** CTO BridgePoint System

**Frequency Threshold:** 0

#### Serious Events

**Term:** Coronary artery atherosclerotic heart disease

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA 10.0

##### Stats

**Group ID:** EG000

**Num Affected:** 4

**Num At Risk:** 20

**Num Events:** 4

**Time Frame:** Baseline,30 days, 6 months and 12 months

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Units:** Participants

### Group

**ID:** BG000

**Title:** CTO BridgePoint System

**Description:** BridgePoint CTO System:

* CrossBoss Catheter
* Stingray LP Catheter
* Stingray Guidewire and Extension Wire single-arm study: single-arm study

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.4

**Value:** 57.5

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 3

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 17

**Category Title:** Male

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Class Title:** 

### Measure

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 0

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 4

**Category Title:** Yes

#### Measurement

**Group ID:** BG000

**Value:** 16

**Category Title:** No

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 18

**Category Title:** Yes

#### Measurement

**Group ID:** BG000

**Value:** 2

**Category Title:** No

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 9

**Category Title:** Yes

#### Measurement

**Group ID:** BG000

**Value:** 11

**Category Title:** No

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 3

**Category Title:** Yes

#### Measurement

**Group ID:** BG000

**Value:** 16

**Category Title:** No

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** Unknown

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 3

**Category Title:** Yes

#### Measurement

**Group ID:** BG000

**Value:** 17

**Category Title:** No

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Yes

#### Measurement

**Group ID:** BG000

**Value:** 20

**Category Title:** No

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 6

**Category Title:** None

#### Measurement

**Group ID:** BG000

**Value:** 5

**Category Title:** Stable angina

#### Measurement

**Group ID:** BG000

**Value:** 8

**Category Title:** Unstable angina

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** Unknown

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Yes

#### Measurement

**Group ID:** BG000

**Value:** 20

**Category Title:** No

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 8

**Category Title:** Yes

#### Measurement

**Group ID:** BG000

**Value:** 12

**Category Title:** No

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Yes

#### Measurement

**Group ID:** BG000

**Value:** 19

**Category Title:** No

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** Unknown

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** Yes

#### Measurement

**Group ID:** BG000

**Value:** 19

**Category Title:** No

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 19

**Category Title:** Yes

#### Measurement

**Group ID:** BG000

**Value:** 1

**Category Title:** No

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Yes

#### Measurement

**Group ID:** BG000

**Value:** 20

**Category Title:** No

#### Denomination

**Units:** Participants

##### Denomination Counts

**Group ID:** BG000

**Value:** 20

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEDIAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Race and Ethnicity were not collected from any participant.
**Title:** Race and Ethnicity Not Collected
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Current diabetes mellitus
**Unit of Measure:** Participants
### Measure 5
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** History of hyperlipidemia requiring medication
**Unit of Measure:** Participants
### Measure 6
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** History of hypertension requiring medication
**Unit of Measure:** Participants
### Measure 7
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Family history of coronary artery disease
**Unit of Measure:** Participants
### Measure 8
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** History of Myocardial Infarction (MI)
**Unit of Measure:** Participants
### Measure 9
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** History of congestive heart failure
**Unit of Measure:** Participants
### Measure 10
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Current anginal status
**Unit of Measure:** Participants
### Measure 11
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Does Subject have silent ischemia
**Unit of Measure:** Participants
### Measure 12
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** History of Percutaneous Coronary Intervention (PCI)
**Unit of Measure:** Participants
### Measure 13
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** History of Coronary Artery Bypass Graft (CABG) surgery
**Unit of Measure:** Participants
### Measure 14
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** History of arrhythmia
**Unit of Measure:** Participants
### Measure 15
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Left Ventricular Ejection Fraction (LVEF) measured
**Unit of Measure:** Participants
### Measure 16
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** History of cardiogenic shock
**Unit of Measure:** Participants
**Population Description:** Subject demographics, Physical assessment, Medical history, Angina assessment, LVEF, Cardiac medication, risk factors, and pre-procedure lesion characteristics will be summarized using descriptive statistics for continuous variables and frequency tables for discrete variables. No formal statistical testing will be done since this is a single-arm trial.
## Results Section - More Information Module
### Certain Agreement
### Limitations and Caveats
**Description:** HGRAC rejected all initiated applications from the leading site without any comments. Only leading site can submit the HGRAC application for multi-center studies and the ban lifting date of leading site is still unclear, it's not allowed to recruit or collect any data from the subjects after Aug 2020 (the expiry date of the approval ). The enrollment speed of FAST CTO is much slower than planning and the scientific value becomes limited due to the delayed data readout anticipation.
### Point of Contact
**Email:** chenchen.fan@bsci.com
**Organization:** BSC
**Phone:** +861085216427
**Title:** Chenchen FAN
## Results Section - Outcome Measures Module
### Outcome Measure 1
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
**Title:** Success
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** Failed
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** 6 subjects have the results data, and 5 of them (83.3%) reported technical success. One (16.7%) failed.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Only 6 subjects have the results of technical success or not.
**Reporting Status:** POSTED
**Time Frame:** Subject follow up will occur via telephone contact or clinic visit at 30 days,6 and 12 months post index procedure.
**Title:** Technical Success: Successfully Facilitate Placement of a Guidewire Beyond a CTO Lesion in the True Vessel Lumen/Within the Collaterals
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** BridgePoint CTO System:

* CrossBoss Catheter
* Stingray LP Catheter
* Stingray Guidewire and Extension Wire

single-arm study: single-arm study
**ID:** OG000
**Title:** CTO BridgePoint System
### Participant Flow Module
#### Group
**Description:** BridgePoint CTO System:

* CrossBoss Catheter
* Stingray LP Catheter
* Stingray Guidewire and Extension Wire

single-arm study: single-arm study
**ID:** FG000
**Title:** CTO BridgePoint System
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** 8 of the 20 subjects already enrolled were unable to complete the the 12-month follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 8
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 20
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 12
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 8
**Has Results:** True