French Observatory Evaluating the Use of Intracoronary Prosthesis ABSORB BVS

French Cardiology Society2,072 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

2,072

Conditions

Intracoronary Angioplasty

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Clinique Saint Hilaire

Rouen, France

Outcomes

Primary Outcomes

Major Adverse Cardiac Events at 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)

Time frame: 1 year

Secondary Outcomes

Target vessel revascularization at 1 year

At 1 year of follow-up, to evaluate the rate of target vessel revascularization (TVR)

Time frame: 1 year

Rate of stent thrombosis at 1 year

At 1 year of follow-up, to evaluate the rate of stent thrombosis as ARC definitions : * acute, subacute, late * probable or undoubted

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.