A Prospective Multicenter Single Arm Study to Assess the Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System for the Treatment of Subjects With Atherosclerotic Lesion(s)
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.
• For sites outside of the United States: Note: For subjects presenting with STEMI and not in a position to read, interpret and sign the informed consent form, oral informed consent is required.
• Subject is an acceptable candidate for percutaneous coronary intervention (PCI) according to the applicable guidelines.
• Subject is an acceptable candidate for CABG.
• Subject is eligible for dual antiplatelet therapy (DAPT) according to guidelines.
• Subject has clinical evidence of ischemic heart disease, stable or unstable angina pectoris or documented silent ischemia.
• Subject is willing and able to comply with study follow-up requirements.
⁃ Angiographic inclusion criteria:
• Subject has only one target lesion in a native coronary artery to be treated with the investigational device.
• Note: One additional non-target lesion may be treated with a non-investigational treatment (e.g. stent, balloon angioplasty, atherectomy) with the exception of brachytherapy, if it is located in a different coronary artery. The non-target lesion must be treated first and must be 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.)
• Note: Multiple focal stenoses will be considered as a single lesion if they are amenable to treatment with a single study device.
• Target lesion must be \> 36 mm and ≤ 44 mm in length by operator visual estimate and must be amenable to treatment with a single study device.
• Target vessel must have a reference vessel diameter of 2.25-4.0 mm by operator visual estimate.
• For sites in United States: Target lesion must be de novo or restenotic lesion in native coronary artery; restenotic lesion must have been treated with a standard PTCA only.
• For sites outside of the United States: Target lesion can be de novo, restenotic or in-stent restenotic, and must be located in a native coronary artery.
• Target lesion must have angiographic evidence of ≥ 50% and \< 100% stenosis (by operator visual estimate which may be assisted by QCA / IVUS / OCT). Target lesion stenosis \< 70% should have clinical justification for treatment as per local standards.
• Target vessel must have a Thrombolysis In Myocardial Infarction (TIMI) flow \> 1.
⁃ For sites outside of the United States: Note: For STEMI, TIMI flow \> 1 prior to stent implantation (after opening the vessel with a guide wire or a balloon).