eBioMatrix

eBiomatrix

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

Center number:

32 centers managed by CERC.

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