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
Parallel
BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stent
DeviceStent implantation
BioFreedom™ stainless steel Biolimus A9™-coated stent
DeviceStent implantation
In-stent late lumen loss (LLL) at 9 months
In-stent late lumen loss (LLL) assessed by quantitative coronary angiography (QCA) at 9 months
All clinical events at protocol defined timepoints
* Cardiovascular Death * Myocardial infarction (according to the Fourth Universal Definition) * TLF (defined as cardiovascular death, target vessel related MI and clinically driven (cd) target lesion revascularization (TLR)) * All-cause mortality * Clinically driven TVR * Stent Thrombosis, per ARC-2 definition of definite/probable * Device success * Procedure success * Lesion success * Bleeding per BARC criteria * BARC 3 to 5 * All BARC * By vascular access site (Femoral/Radial)
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