A French Post-market Observational/Non-interventional Study of the BioMatrix Flex™ and BioMatrix Neo Flex™ Drug Eluting Stents With 6-month DAPT
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Biosensors Europe SA
- Enrollment
- 2,098
- Primary Endpoint
- Major adverse cardiac and cerebrovascular events (MACCE) in the overall population, defined as composite of all-cause death, cerebrovascular accidents, non fatal myocardial infarction or clinically-driven target vessel revascularization at 6 months
Study Overview
Brief Summary
Prospective, multi-center observational study to be conducted in up to 30 French interventional cardiology centers. The purpose of this observational study is to capture, in French Centers, clinical data of the BioMatrix Flex™ and BioMatrix NeoFlex™ Drug Eluting Coronary Stents System (Biolimus A9, BA9™-) in normal practice, in patients treated with 6-month DAPT, and to compare the outcomes to those of previous e-biomatrix registries with longer DAPT durations. The patients will be followed up for 2 years for data collection.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •"Real world, all comer" patients
- •Age ≥18 years;
- •Patients that need a treatment with a BioMatrix Flex™ drug- eluting stent or a BioMatrix NeoFlex™drug-eluting stent;
- •Presence of one or more coronary artery stenoses in a native coronary artery from 2.25 to 4.0 mm in diameter that can be covered with one or multiple stents;
- •No limitation on the number of treated lesions, vessels, and lesion length, within the limits of social security reimbursements;
- •Patient with DAPT indication after PCI.
Exclusion Criteria
- •Inability to provide informed consent;
- •Patients needing additional stent NOT of the BioMatrix Flex™ or NeoFlex™ types;
- •Patients receiving next to the BioMatrix Flex™ or BioMatrix NeoFlex™ also other coronary vascular interventions, for example, balloon dilation;
- •Pregnant or planning to become pregnant patient;
- •DES and BMS implantation less than 6 months before screening;
Outcomes
Primary Outcomes
Major adverse cardiac and cerebrovascular events (MACCE) in the overall population, defined as composite of all-cause death, cerebrovascular accidents, non fatal myocardial infarction or clinically-driven target vessel revascularization at 6 months
Time Frame: 6 months
Major adverse cardiac and cerebrovascular events (MACCE) in the overall population, defined as composite of all-cause death, cerebrovascular accidents, non fatal myocardial infarction or clinically-driven target vessel revascularization at 6 months
Secondary Outcomes
- Cardiac deaths at 6 months and and 2 years(6 months and and 2 years)
- Death,MI and cerebrovascular accidents at 6 months and 2 years(6 months and 2 years)
- Major adverse cardiac and cerebrovascular events (MACCEs) in the overall population(2 years)
- Primary and secondary stent thrombosis(6 months and 2 years)
- Major bleeding(6 months and 2 years)
- Patient Oriented Composite Endpoint defined as any cause mortality, MI (Q-wave and non-Q-wave), or any revascularization at 6 months and 2 years(6 months and 2 years)
- Death, post-procedural MI and cerebrovascular accidents at 6 months and 2 years(6 months and 2 years)