Post-Market Registry of the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System Collecting Real-World Data After PCI with 1-Year Follow-Up

What this Trial Is About

Researchers are collecting real-world data on the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System in patients who have undergone percutaneous coronary intervention PCI. This prospective, observational registry study involves up to 10,000 patients treated at up to 150 cardiology centers across Europe, South America, the Middle East, and Asia over five years. The study provides post-market clinical follow-up as part of ongoing post-market surveillance. Participants receive the BioFreedom Ultra device, which consists of a cobalt chromium stent platform coated on the outside with the active ingredient BA9, without polymer or carrier. The study observes the use of this device in standard clinical practice without altering patient care. Patients are monitored mainly through telephone or clinic visits one year after PCI. During the study, participants will be followed for 12 months to collect data on outcomes such as target lesion failure, clinically driven target lesion revascularization, cardiovascular death, target vessel myocardial infarction, target vessel revascularization, and stent thrombosis. Follow-up assessments are conducted primarily by phone, ensuring safety monitoring and data collection in a real-world setting with minimal disruption to participants routine care.

eUltra 10k - Biofreedom Ultra