e-BioMatrix 6 Month DAPT France
Launched by BIOSENSORS EUROPE SA · Mar 5, 2018
Trial Information
Current as of May 14, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- 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;
About Biosensors Europe Sa
Biosensors Europe SA is a leading medical technology company focused on the development and commercialization of innovative diagnostic and therapeutic solutions. With a commitment to advancing patient care, the company specializes in biosensor technologies that enhance clinical outcomes through precise and reliable monitoring. Biosensors Europe SA collaborates with healthcare professionals and research institutions to drive clinical trials aimed at validating new applications and improving existing products, ensuring a robust pipeline of cutting-edge healthcare solutions. Their dedication to quality and innovation positions them as a trusted partner in the medical device industry.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Christian Spaulding, MD
Principal Investigator
Hôpital Européen Georges-Pompidou
Lanusz Lipiecki, MD
Principal Investigator
Clinique des Dômes
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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