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.
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).
All except for statistical analysis:
Study start-up activities
Clinical trial documentation
Final clinical report