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 BioFreedom^TM 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

Centers number

25