The purpose of the study is to assess the safety and efficacy of the Orsiro® Mission 48- mm Sirolimus-Eluting Coronary Stent System in the treatment of subjects with atherosclerotic lesion(s) \>36 mm and ≤ 44 mm in length (by visual estimate) in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm.
Patients enrolled in the United States will be followed for 2 years post index procedure with follow-up visits at 1, 6, 12 months and 2 years post index procedure. Patients enrolled outside of the United States will be followed through 5 years post index procedure with additional follow-up visits at 3 and 5 years post index procedure.
Subject is ≥ 18 years of age
Subject is able to understand the nature of the study and provide written informed consent.
Subject is an acceptable candidate for percutaneous coronary intervention (PCI) according to the applicable guidelines.
Subject is an acceptable candidate for CABG.
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.
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 or sirolimus.
Single group
Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System
DeviceOrsiro Mission is composed of a device (coronary stent system including a cobalt chromium stent platform) and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
Target Lesion Failure (TLF) rate at 12 months post-index procedure
The primary endpoint will be target lesion failure (TLF) rate at 12 months post-index procedure. TLF is defined as a composite of cardiac death, target vessel Q-wave or non-Q-wave myocardial infarction (TV-MI), or clinically driven target lesion revascularization (CD-TLR).
Device success
Device success, defined as attainment of \< 30% residual stenosis of the target lesion (based on operator visual estimate) using the Orsiro Mission study stent only.
Procedure success
Procedure success, defined as attainment of \< 30% residual stenosis of the target lesion (based on operator visual estimate) using the Orsiro Mission study stent only without occurrence of in-hospital major adverse cardiac events (MACE).
All-cause death
Any myocardial infarction (MI)
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Teleflex
Lead sponsor
BIOTRONIK AG (A Teleflex Company)
Collaborator
