French Observatory Evaluating the Use of Intracoronary Prosthesis ABSORB BVS

• Register: ClinicalTrials.gov
• Last refreshed on: 3 October 2022
• Main ID: NCT02238054
• Date of registration: 10/09/2014
• Prospective Registration: No
• Primary sponsor: French Cardiology Society
• Public title: French Observatory Evaluating the Use of Intracoronary Prosthesis ABSORB BVS FRANCE-ABSORB
• Scientific title: French Observatory Evaluating the Use of Intracoronary Prosthesis ABSORB BVS
• Date of first enrolment: September 2014
• Target sample size: 2072
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02238054
• Study type: Observational [Patient Registry]

Countries of recruitment

France

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Intracoronary Angioplasty

Primary Outcome(s)

Major Adverse Cardiac Events at 1 year [Time Frame: 1 year]

Secondary Outcome(s)

Rate of stent thrombosis at 1 year [Time Frame: 1 year]

Target vessel revascularization at 1 year [Time Frame: 1 year]

Secondary ID(s)

14249

Source(s) of Monetary Support

Please refer to primary and secondary sponsors