Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions
Eligible age
18+ yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
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About this study
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.
Sponsor: Teleflex
You may qualify if…
- ✓ 1. Subject is ≥ 18 years of age
- ✓ 2. 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.
- ✓ 3. Subject is an acceptable candidate for percutaneous coronary intervention (PCI) according to the applicable guidelines.
- ✓ 4. Subject is an acceptable candidate for CABG.
- ✓ 5. Subject is eligible for dual antiplatelet therapy (DAPT) according to guidelines.
- ✓ 6. Subject has clinical evidence of ischemic heart disease, stable or unstable angina pectoris or documented silent ischemia.
- ✓ 7. Subject is willing and able to comply with study follow-up requirements.
You may not qualify if…
- ✕ 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.
Where it's recruiting
Concord
Wichita
Boston
Detroit
St Louis
Manhasset · New York
Dallas · Kyle
Charleston
Source: ClinicalTrials.gov · NCT06779630 · last updated 2026-07-24