e-BioMatrix 6 Month DAPT France

Completed

• Conditions: Coronary Artery Stenoses; Stable Angina; Ischemia; NSTEMI - Non-ST Segment Elevation MI; STEMI

• Registration Number: NCT03461484
• Lead Sponsor: Biosensors Europe SA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-06
• Study First Submitted: 2018-03-05
• Study First Submitted QC: 2018-03-05
• Study First Posted: 2018-03-12
• Primary Completion: 2018-04-09
• Status Verified: 2019-05
• Study Completion: 2019-10-31
• Last Update Submitted: 2020-04-14
• Last Update Posted: 2020-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2098

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
Cardiac deaths at 6 months and and 2 years	6 months and and 2 years	Cardiac deaths at 6 months and and 2 years
Death,MI and cerebrovascular accidents at 6 months and 2 years	6 months and 2 years	Death,MI and cerebrovascular accidents at 6 months and 2 years
Major adverse cardiac and cerebrovascular events (MACCEs) in the overall population	2 years	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
Primary and secondary stent thrombosis	6 months and 2 years	Primary and secondary stent thrombosis (definite and probable according to ARC definitions) at 6 months and 2 years;
Major bleeding	6 months and 2 years	Major bleeding (BARC 3, 4 and 5 definitions) at 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	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
Death, post-procedural MI and cerebrovascular accidents at 6 months and 2 years	6 months and 2 years	Death, post-procedural MI and cerebrovascular accidents at 6 months and 2 years