Trial for A Novel Facilitated Antegrade Steering Technique in Revascularization of Coronary Chronic Total Occlusions

NCT03901079 | Terminated Results

• 1 other identifier: S2362
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

CAD

Outcome Measures

Primary Outcomes (1)

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

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

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

Study Arms (1)

CTO BridgePoint system

BridgePoint CTO System: * CrossBoss Catheter * Stingray LP Catheter * Stingray Guidewire and Extension Wire

Other: single-arm study

Interventions

single-arm study OTHER

single-arm study

CTO BridgePoint system

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• 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°)

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (1)

West China Hospital Sichuan University

Chengdu, Sichuan, 610041, China

Location

Limitations and Caveats

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.

Results Point of Contact

• Title: Chenchen FAN
• Organization: BSC

chenchen.fan@bsci.com

+861085216427

Study Officials

• Yuejin Yang, Doc.

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: April 3, 2019
• Study Start: October 8, 2018
• Primary Completion: January 10, 2020
• Study Completion: March 24, 2021
• Last Updated: December 8, 2023
• Results First Posted: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)