e-BioMatrix 6 Month DAPT France

Biosensors Europe SA2,098 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

2,098

Conditions

Coronary Artery Stenoses Stable Angina Ischemia NSTEMI - Non-ST Segment Elevation MI STEMI

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * "Real world, all comer" patients 1. Age ≥18 years; 2. Patients that need a treatment with a BioMatrix Flex™ drug- eluting stent or a BioMatrix NeoFlex™drug-eluting stent; 3. 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; 4. No limitation on the number of treated lesions, vessels, and lesion length, within the limits of social security reimbursements; 5. Patient with DAPT indication after PCI. Exclusion Criteria: 1. Inability to provide informed consent; 2. Patients needing additional stent NOT of the BioMatrix Flex™ or NeoFlex™ types; 3. Patients receiving next to the BioMatrix Flex™ or BioMatrix NeoFlex™ also other coronary vascular interventions, for example, balloon dilation; 4. Pregnant or planning to become pregnant patient; 5. 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

Secondary Outcomes

Primary and secondary stent thrombosis

Primary and secondary stent thrombosis (definite and probable according to ARC definitions) at 6 months and 2 years;

Time frame: 6 months and 2 years

Major bleeding

Major bleeding (BARC 3, 4 and 5 definitions) at 6 months and 2 years

Time frame: 6 months and 2 years

Major adverse cardiac and cerebrovascular events (MACCEs) in the overall population

Major adverse cardiac and cerebrovascular events (MACCEs) in the overall population, defined as composite of all cause death, myocardial infarction (Q-wave and non-Q-wave), cerebrovascular accidents or clinically-driven target vessel revascularization at 2 years

Time frame: 2 years

Cardiac deaths at 6 months and and 2 years

Time frame: 6 months and 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

Time frame: 6 months and 2 years

Death,MI and cerebrovascular accidents at 6 months and 2 years

Time frame: 6 months and 2 years

Death, post-procedural MI and cerebrovascular accidents at 6 months and 2 years

Time frame: 6 months and 2 years