NCT03745066

BioFreedom French Registry

A Post-Market Registry of the BioFreedomTM Biolimus A9TM Coated Coronary Stent System

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: Biosensors Europe SA · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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 registry will be purely observational and will not interfere with physician's decisions relating to stent selection or indication for treatment. 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

• Coronary Artery Disease

Timeline

• Start date: 2019-04-04
• Primary completion: 2021-04-30
• Completion: 2022-04-27
• First posted: 2018-11-19
• Last updated: 2021-04-26

Locations

6 sites across 1 country: France