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Search / Trial NCT03461484

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.

Locations

Patients applied

0 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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