french biofreedom

Brief summary

This is a prospective, observational/non-interventional multi-center registry to be conducted at up to 25 French interventional cardiology centers. The purpose of the study 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.

Primary endpoints

Device-oriented composite endpoint (DOCE) at 12 months defined as composite of cardiovascular death (CD), myocardial infarction (MI) not clearly attributable to a non-target vessel and clinically driven target lesion revascularization (cd-TLR).

CERC Services

All except for statistical analysis:

Study start-up activities

Clinical trial documentation

Project management

eCRF

Data management

Monitoring

CEC activities

Safety management

Final clinical report

Countries

France

Center number

25