French Observatory Evaluating the Use of Intracoronary Prosthesis ABSORB BVS (FRANCE-ABSORB)

French Cardiology Society

Status: Completed

Conditions: Intracoronary Angioplasty

Study type: Observational

Funder types: Other

Identifiers

NCT02238054

14249

Details and patient eligibility

About

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

Enrollment: 2,072 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

2,072 participants in 1 patient group

ABSORB BVS

Description:

All patients with a coronary angioplasty procedure and the implantation of at least one ABSORB BVS