Clinical trial NCT02238054: French Observatory Evaluating the Use of Intracoronary Prosthesis ABSORB BVS
Official title: French Observatory Evaluating the Use of Intracoronary Prosthesis ABSORB BVS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracoronary Angioplasty
Keywords: Cardiology
Intracoronary angioplasty
Bioresorbable stent
Lead sponsor: French Cardiology Society
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 2072
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the departments of Cardiology, from French health institutions, who are authorized to implement, may participate in the observatory.

It is estimated that this procedure will be performed by 50 to 60 sites performing the installation of BVS. The list of centers is scalable, their number can be expected to increase.

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


Eligibility criteria: 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

Primary outcomes:
measure: Major Adverse Cardiac Events at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Target vessel revascularization at 1 year
timeFrame: 1 year
measure: Rate of stent thrombosis at 1 year
timeFrame: 1 year
Other outcomes:
Locations:
city: Rouen
country: France
facility: Clinique Saint Hilaire
Study officials:
References:
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