Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus Eluting Coronary Stent System in S… (NCT06779630) | Clinical Trial Compass
RecruitingNot Applicable
Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
United States150 participantsStarted 2025-07-18
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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.
✓. Subject has only one target lesion in a native coronary artery to be treated with the investigational device.
Exclusion criteria
✕. 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.
What they're measuring
1
Target Lesion Failure (TLF) rate at 12 months post-index procedure
✕. 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.
✕. 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.
✕. Future planned PCI (including staged procedure) or CABG after the index procedure.
✕. Planned surgery or dental surgical procedure 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.