Trials / Completed
CompletedNCT03461484
e-BioMatrix 6 Month DAPT France
A French Post-market Observational/Non-interventional Study of the BioMatrix Flex™ and BioMatrix Neo Flex™ Drug Eluting Stents With 6-month DAPT
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,098 (actual)
- Sponsor
- Biosensors Europe SA · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2014-03-06
- Primary completion
- 2018-04-09
- Completion
- 2019-10-31
- First posted
- 2018-03-12
- Last updated
- 2020-04-15
Source: ClinicalTrials.gov record NCT03461484. Inclusion in this directory is not an endorsement.