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

September 20, 2022 updated by: French Cardiology Society

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2072

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France
        • Clinique Saint Hilaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 year
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

French Cardiology Society

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

May 30, 2022

Study Registration Dates

First Submitted

September 10, 2014

First Submitted That Met QC Criteria

September 10, 2014

First Posted (Estimate)

September 12, 2014

Study Record Updates

Last Update Posted (Actual)

September 22, 2022

Last Update Submitted That Met QC Criteria

September 20, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 14249

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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