Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions (BIOFLOW-48) Study

Eligibility Criteria

• 1. Subject is ≥ 18 years of age
• 2. Subject is able to understand the nature of the study and provide written informed consent.
• 3. Subject is an acceptable candidate for percutaneous coronary intervention (PCI) according to the applicable guidelines.
• 4. Subject is an acceptable candidate for CABG.
• 5. Subject is eligible for dual antiplatelet therapy (DAPT) according to guidelines.
• 6. Subject has clinical evidence of ischemic heart disease, stable or unstable angina pectoris or documented silent ischemia.
• 7. Subject is willing and able to comply with study follow-up requirements.
• 1. For sites in United States only: Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with acute ST elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure.
• 2. Subject is hemodynamically unstable.
• 3. Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.
• 4. Subject has a known allergy to contrast medium that cannot be adequately pre-medicated, or any known allergy to thienopyridine, aspirin, both heparin and bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten and nickel), acrylic, fluoropolymers, silicon carbide, PLLA or sirolimus.
• 5. Revascularization of any target vessel within 12 months prior to the index procedure or previous PCI of any non-target vessel within \<72 hours prior to the index procedure.
• 6. Future planned PCI (including staged procedure) or CABG after the index procedure.
• 7. Planned surgery or dental surgical procedure within 6 months of index procedure unless dual antiplatelet therapy can be maintained throughout the peri-surgical period.
• 8. History of a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure.
• 9. Subjects with active bleeding disorders, active coagulopathy, or any other reason, who are ineligible for DAPT.
• 10. Subject will refuse blood transfusions.
• 11. Subject has a left ventricular ejection fraction (LVEF) \< 30% within 6 months prior to or during the index procedure that was documented by any method.
• 12. Subject is dialysis dependent or has impaired renal function (i.e., serum creatinine \> 2.5 mg/dL or 221 µmol/L, determined within 7 days prior to the index procedure).
• 13. Subject has a documented white blood cell count \< 3,000 white blood cells/mm3 or a documented platelet count \< 100,000 platelets/mm3 or \> 700,000 platelets/mm3.
• 14. Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are permitted) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus is permitted).
• 15. Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure or has a malignancy that is not in remission.
• 16. Subjects under oral anticoagulation therapy (OAC) prior to index procedure unless DAPT + OAC (i.e. triple therapy) can be maintained according to guidelines.
• 17. Subject has life expectancy of \< 1 year.
• 18. Subject is currently participating or plans to participate in another clinical investigation with an investigational device or an investigational drug.
• 19. In the investigator's opinion, subject will not be able to comply with the follow-up requirements.