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

Exclusion Criteria

• •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.
• •Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment.
• •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.
• •1. Target lesion is excluded if it meets any of the following criteria:
• •1. Lesion is located within or treated through a saphenous vein graft or arterial graft.
• •2. Lesion location is within the left main coronary artery.
• •3. Lesion location is within 3 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX) coronary arteries.
• •4. Involves a side branch of \> 2.0 mm in diameter that requires a two-device strategy after pre-dilatation.
• •5. Lesion is totally occluded (100% stenosis).
• •6. For sites in United States only: Lesion is a restenotic lesion that was previously treated with a bare metal or drug eluting stent (in-stent restenosis).
• •2. Target vessel/lesion is excessively tortuous/angulated or is severely calcified, that would prevent complete inflation of an angioplasty balloon. This assessment should be based on visual estimation.
• •3. Site sites in the United States: Target vessel has angiographic evidence of thrombus.
• •For sites outside of the United States: Target vessel has angiographic evidence of unresolved large thrombus burden despite of thrombus aspiration.
• •Note: Thrombus aspiration is left at the discretion of the implanting physician.
• •4. Target vessel was treated with brachytherapy any time prior to the index procedure.
• •5. Unsuccessful target lesion pre-dilatation, defined as residual stenosis \> 50% (by visual estimation) and/or angiographic complications (e.g., distal embolization, side branch closure, dissection greater than National Heart, Lung, Blood Institute type C), and/or, for sites outside of the United States, coronary aneurysms.
• •6. Non-target lesion is excluded if it meets any of the following criteria:
• •2. Lesion is located within the target vessel.
• •3. Lesion is \> 36 mm by operator visual estimate.
• •4. Lesion requires additional, unplanned stents to treat a complication.
• •5. Lesion treatment is not deemed an angiographic success. (Angiographic success is defined by a residual diameter stenosis \< 30% with TIMI 3 flow, as visually assessed by the physician, without the presence of prolonged chest pain or ECG changes consistent with MI.)