French Observatory Evaluating the Use of Intracoronary Prosthesis ABSORB BVS

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02238054

Acronym

FRANCE-ABSORB

Enrollment

2072

Registered

2014-09-12

Start date

2014-09-30

Completion date

2022-05-30

Last updated

2022-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracoronary Angioplasty

Keywords

Cardiology, Intracoronary angioplasty, Bioresorbable stent

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

France

Outcome results