French Observatory Evaluating the Use of Intracoronary Prosthesis ABSORB BVS

Completed

• Conditions: Intracoronary Angioplasty

• Registration Number: NCT02238054
• Lead Sponsor: French Cardiology Society

Brief Summary

Observational Study, French, prospective, multicenter rated using intravascular prosthesis ABSORB BVS.

ABSORB BVS is a prosthesis of a new type. This study will prospectively evaluate all procedures for coronary angioplasty with implantation of at least one BVS with a clinical follow-up of all patients implanted with ABSORB BVS. This national observatory will collect all the events related to product and / or to procedure

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-10
• Study First Submitted QC: 2014-09-10
• Study First Posted: 2014-09-12
• Primary Completion: 2017-09
• Study Completion: 2022-05-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-20
• Last Update Posted: 2022-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2072

Inclusion Criteria

• Patient affiliated to the National Health Insurance Scheme
• Patient able to assess and understand the risks, benefits and alternative treatments laying of ABSORB, to agree to participate in the study (by signing the informed consent after having read the newsletter)
• Patients for whom a procedure is performed coronary angioplasty with implantation of at least one BVS.
• Patient allowing the follow-up as defined in the study

Exclusion Criteria

• Pregnant patient
• Patient that can not give informed consent
• Patient with in-stent restenosis or saphenous vein bypass

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events at 1 year	1 year	At 1 year of follow-up, to evaluate the rate of MACE (Major Adverse Cardiac Events) defined as follows: * Death from cardiac causes; * Myocardial Infarction; * Rates of target lesion revascularization (TLR) of ischemic origin (ID-TLR); * Surgery unscheduled bypass graft (CABG)

Secondary Outcome Measures

Name	Time	Method
Target vessel revascularization at 1 year	1 year	At 1 year of follow-up, to evaluate the rate of target vessel revascularization (TVR)
Rate of stent thrombosis at 1 year	1 year	At 1 year of follow-up, to evaluate the rate of stent thrombosis as ARC definitions : * acute, subacute, late; * probable or undoubted

Trial Locations

Locations (1)

Clinique Saint Hilaire; 🇫🇷 Rouen, France