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Completed

NCT Number: NCT02238054

French Observatory Evaluating the Use of Intracoronary Prosthesis ABSORB BVS

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

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Key information

Conditions

Intracoronary Angioplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Saint Hilaire

Rouen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Major Adverse Cardiac Events at 1 year

    Time frame: 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 outcomes

  1. Target vessel revascularization at 1 year

    Time frame: 1 year

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

  2. Rate of stent thrombosis at 1 year

    Time frame: 1 year

    At 1 year of follow-up, to evaluate the rate of stent thrombosis as ARC definitions :

    • acute, subacute, late
    • probable or undoubted

Sponsors and collaborators

Lead sponsor

French Cardiology Society

Other

Registry information

Acronym: FRANCE-ABSORB

Important dates

Study start
2014
Primary completion
2017
Study completion
2022
First posted
Sep 12, 2014
Registry last updated
Sep 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.