This study aims to demonstrate that the BioFreedom™ Ultra Drug Coated Stent (DCS) is non-inferior to the BioFreedom™ DCS, with respect to in-stent late lumen loss, and that it has safety characteristics similar to the BioFreedom™ DCS.
Patients at high bleeding risk (HBR) with an indication for PCI who can tolerate at least one month of DAPT. This includes patients with stable angina, silent ischemia, acute coronary syndromes (ACS) (STEMI and NSTEMI), de novo lesions in native arteries with diameter stenosis >70% by visual estimation and evidence of ischemia in the territory of the target vessel(s).
Patients meet ARC-HBR definition i.e at least 1 major or 2 minor criteria.
Pregnant and breastfeeding women
Age <18 years old
Patients lacking capacity (i.e. patients suffering from dementia and others) to provide informed consent
Patients expected not to comply with 1 month DAPT
Biosensors Europe SA
Lead sponsor