BioFreedom French Registry
NCT03745066 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1500
Last updated 2021-04-26
Summary
Prospective, observational multi-center registry to be conducted at up to 25 French interventional cardiology centers. Patients will be eligible once they have received at least one BioFreedomTM DCS as per standard clinical practice and will be followed for up to 2 years post PCI for data collection.
The purpose of the registry is to explore the safety and effectiveness of the BioFreedomTM DCS in standard clinical practice in France and to serve as part of Post Market Surveillance.
Conditions
Sponsors & Collaborators
-
European Cardiovascular Research Center
collaborator NETWORK -
Biosensors Europe SA
lead INDUSTRY
Principal Investigators
-
Janusz Lipiecki, MD · Clinique des Dômes
-
Philippe Garot, MD · ICPS, Massy
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-04-04
- Primary Completion
- 2021-04-30
- Completion
- 2022-04-27
Countries
- France
Study Locations
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