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

Inclusion Criteria

• Subject is ≥18 years or the minimum age required for legal adult consent in the country of enrollment.
• Subject is an acceptable candidate for PCI.
• Subject is an acceptable candidate for CABG.
• Subject has clinical evidence of ischemic heart disease, stable or unstable angina pectoris or documented silent ischemia.
• Subject is eligible for dual anti-platelet therapy treatment with aspirin plus either, clopidogrel, prasugrel, ticagrelor or ticlopidine.
• Subject has provided written informed consent.
• Subject is willing to comply with study follow-up requirements.

Each target lesion/vessel must meet all of the following angiographic criteria for the subject to be eligible for the trial:

• Subject has up to three target lesions in up to two separate target vessels (two target lesions in one vessel and one target lesion in a separate vessel).
• Target lesion must be de novo or restenotic lesion in native coronary artery; restenotic lesion must have been treated with a standard PTCA only.
• Target lesion must be in major coronary artery or branch (target vessel).
• Target lesion must have angiographic evidence of ≥ 50% and 1.
• Target lesion must be ≤ 36 mm in length by operator visual estimate.
• Target vessel RVD of 2.25-4.0 mm by operator visual estimate.
• Target lesion must be treatable with a maximum of two overlapping stents.

Exclusion Criteria

• 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. Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment.
• Subject is hemodynamically unstable.
• Subject is pregnant and/or breastfeeding or intends to become pregnant during the duration of the study.
• 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, sirolimus or everolimus.
• Revascularization of any target vessel within 9 months prior to the index procedure or previous PCI of any non-target vessel within 30 days prior to the index procedure.
• Planned treatment of a lesion not meeting angiographic inclusion and exclusion criteria during the index procedure or after the index procedure.
• Planned surgery within 6 months of index procedure unless dual antiplatelet therapy can be maintained throughout the peri-surgical period.
• History of a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure.
• Subjects with active bleeding disorders, active coagulopathy, or any other reason, who are ineligible for DAPT.
• Subject will refuse blood transfusions.
• Subject has documented left ventricular ejection fraction (LVEF) 2.5 mg/dL or 221 μmol/L determined within 7 days prior to the index procedure).
• Subject has leukopenia (i.e. 700,000 platelet/mm3).
• 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).
• Subject is receiving chronic anticoagulation (e.g. coumadin, dabigatran, apixaban, rivaroxaban or any other agent).
• Subject has life expectancy of 2.0 mm in diameter. Note: Lesions within 3 mm of the origin of the right coronary artery may be treated.
• 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.
• Target vessel has angiographic evidence of thrombus.
• Target lesion is totally occluded (100% stenosis).
• Target vessel was treated with brachy