BioFreedom French Registry

NCT03745066 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1500

Last updated 2021-04-26

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03745066 on ClinicalTrials.gov