Brief summary

A French post-market Observational/Non-interventional Study of the BioMatrix Flex™ and BioMatrix NeoFlex™drug eluting stents with 6-month DAPT.

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.

Primary endpoints

• 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.

CERC Services

• Study start-up activities,
• Clinical trial documentation,
• Project management,
• eCRF,
• Data management,
• Monitoring,
• CEC activities,
• Safety management,
• DSMB management,
• Statistical activities,
• Final clinical report.

Countries

France

Centers number

32 centers managed by CERC.