Status:
COMPLETED
e-BioMatrix 6 Month DAPT France
Lead Sponsor:
Biosensors Europe SA
Collaborating Sponsors:
European Cardiovascular Research Center
Conditions:
Coronary Artery Stenoses
Stable Angina
Eligibility:
All Genders
18+ years
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 d...
Eligibility Criteria
Inclusion
- "Real world, all comer" patients
- Age ≥18 years;
- Patients that need a treatment with a BioMatrix Flex™ drug- eluting stent or a BioMatrix NeoFlex™drug-eluting stent;
- 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;
- No limitation on the number of treated lesions, vessels, and lesion length, within the limits of social security reimbursements;
- Patient with DAPT indication after PCI.
Exclusion
- Inability to provide informed consent;
- Patients needing additional stent NOT of the BioMatrix Flex™ or NeoFlex™ types;
- Patients receiving next to the BioMatrix Flex™ or BioMatrix NeoFlex™ also other coronary vascular interventions, for example, balloon dilation;
- Pregnant or planning to become pregnant patient;
- DES and BMS implantation less than 6 months before screening;
Key Trial Info
Start Date :
March 6 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2019
Estimated Enrollment :
2098 Patients enrolled
Trial Details
Trial ID
NCT03461484
Start Date
March 6 2014
End Date
October 31 2019
Last Update
April 15 2020
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