UltraExtend: BioFreedom Ultra

The goal of this Prospective, multi-center, open-label single-arm study is to Assess the Safety and Effectiveness of additional sizes of the BioFreedom Ultra CoCr Biolimus A9 coated coronary stent system in Patients at high risk of bleeding (HBR). The main question it aims to answer is to evaluate if the additional sizes of the BioFreedom Ultra have corresponding clinical safety and efficacy characteristics as the regulatory approved (=CE Marked) sizes.

Inclusion Criteria:Clinical:Patients at high bleeding risk (HBR) with an indication for PCI. This includes candidates with stable & unstable angina, silent ischemia, NSTEMI and de novo lesions in native arteries. Patients must provide written informed consent.Reasons of unsuitability for > 1 month dual antiplatelet treatment must include one or MORE of the following:Adjunctive oral anticoagulation treatment planned to continue after PCIAge ≥75 years oldBaseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to inclusion into the study)Any prior intracerebral bleedAny stroke in the last 12 monthsHospital admission for bleeding during the prior 12 monthsNon skin cancer diagnosed or treated <3 yearsPlanned daily NSAID (other than aspirin) or steroids for ≥30 days after PCIPlanned surgery that would require interruption of DAPT (within next 12 months)Renal failure defined as: Creatinine clearance <40 ml/minThrombocytopenia (platelet count (PLT) <100,000/mm3)Severe chronic liver disease defined as: patients who have developed any of the following: ariceal hemorrhage, ascites, hepatic encephalopathy or jaundiceExpected non-compliance to prolonged DAPT for other medical reasonsAngiographic Inclusion Criteria:Reference vessel diameter between 2.25 - 4.2 mm by visual estimation, depending on the stent size usedTarget lesion length >28 mm by visual estimation, depending on the stent size usedTarget lesion must have visually estimated stenosis ≥ 50%, de novo lesionExclusion Criteria:Pregnant and breastfeeding womenAge < 18 years oldPatients lacking capacity (i.e. patients suffering from dementia and others) to provide informed consentPatients expected not to comply with 1 month DAPTPatients requiring a planned staged PCI procedure more than one week after the index procedureSubject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation MI (STEMI)Procedure requires the use of non-study stents in target vessel during index procedure 8. Active bleeding at the time of inclusion9. Cardiogenic shock 10. Compliance with long-term single anti-platelet therapy unlikely 11. Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any other P2Y12 inhibitor if applicable), cobalt chromium, zinc, Biolimus A9 or a sensitivity to contrast media, which cannot be adequately pre-medicated 12. Currently participating in another trial before reaching primary endpoint 13. Patients with a life expectancy of < 1 year 14. Patients under judicial protection, tutorship or curatorship