ULTRA LONG: BioFreedom Ultra

Clinical:

1. Patients at high bleeding risk (HBR) with an indication for PCI. This includessubjects with chronic coronary syndrome, unstable angina, or non-ST elevationmyocardial infarction.

2. Patients must provide written informed consent

3. Patient is at least 18 years old

4. Patients with a life expectancy of > 1 year at time of consent

5. HBR patients defined according to the ARC-HBR criteria and suitable to receive dualanti platelet therapy (DAPT) for one month. To be qualified HBR, patients have tohave at least 1 major and/or 2 minor criteria defined as follow: Major Minor Age ≥75 years old Anticipated use of long-term oral anticoagulation*Severe or end-stage CKD (eGFR <30 mL/min) Moderate CKD (eGFR 30-59 mL/min)Hemoglobin <11 g/dL Hemoglobin 11-12.9 g/dL for men and 11-11.9 g/dL for womenSpontaneous bleeding requiring hospitalization or transfusion in the past 6 monthsor at any time, if recurrent Spontaneous bleeding requiring hospitalization ortransfusion within the past 12 months not meeting the major criterion Moderate orsevere baseline thrombocytopenia† (platelet count <100×109/L) Chronic bleedingdiathesis Liver cirrhosis with portal hypertension Long-term use of oral NSAIDs orsteroids Active malignancy‡ (excluding non-melanoma skin cancer) within the past 12months Previous spontaneous ICH (at any time) Previous traumatic ICH within the past 12 months Presence of a bAVM Moderate or severe ischemic stroke§ within the past 6months Any ischemic stroke at any time not meeting the major criterion Nondeferrablemajor surgery on DAPT Recent major surgery or major trauma within 30 days before PCIbAVM indicates brain arteriovenous malformation; CKD, chronic kidney disease; DAPT,dual antiplatelet therapy; eGFR, estimated glomerular filtration rate; HBR, highbleeding risk; ICH, intracranial hemorrhage; NSAID, nonsteroidal anti-inflammatorydrug; and PCI, percutaneous coronary intervention.

*This excludes vascular protection doses.

†Baseline thrombocytopenia is defined as thrombocytopenia before PCI.

‡Active malignancy is defined as diagnosis within 12 months and/or ongoingrequirement for treatment (including surgery, chemotherapy, or radiotherapy).

§National Institutes of Health Stroke Scale score ≥5. Angiographic:

6. Patients scheduled to undergo PCI of a de novo lesion (no in-stent restenosis) withreference vessel diameter and lesion length suitable for treatment with at least onestudy device

Exclusion Criteria:

1. Pregnant and breastfeeding women

2. Patients lacking capacity (i.e. patients suffering from dementia and others) toprovide informed consent

3. Patients not expected to comply with 1 month of DAPT

4. Staged procedures in the target vessel

5. Active bleeding at the time of inclusion

6. Cardiogenic shock

7. Unlikely compliance with long-term single anti-platelet therapy

8. Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any otherP2Y12 inhibitor if applicable), cobalt chromium, zinc, Biolimus A9 or a sensitivityto contrast media, which cannot be adequately pre-medicated

9. Currently participating in another trial before reaching primary endpoint

10. Patients under judicial protection, tutorship or curatorship (France only)