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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P170030 S058/ PAS001 |
| Date Original Protocol Accepted |
08/07/2026
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| Date Current Protocol Accepted |
08/07/2026
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| Study Name |
EVO Extended Diameter PAS
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| Device Name |
Orsiro Mission Sirolimus Eluting Coronary Stent System
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
Sponsor Registry
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
The purpose of this post-approval study is to confirm the clinical performance of the OrsiroTM MissionTM 4.5 mm and 5.0 mm diameter Sirolimus-Eluting Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) in the native coronary arteries with a reference vessel diameter of 4.5 mm to 5.0 mm (by visual estimate) and a lesion length of less than 26 mm (by visual estimate). This clinical trial will be prospective, multicenter, single-arm, observational study.
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| Study Population |
Subjects with coronary artery disease (CAD), including those with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, ST elevation myocardial infarction, non- ST elevation myocardial infarction or documented silent ischemia due to atherosclerotic lesions in the native coronary arteries with a reference vessel diameter of 4.5 mm to 5.0 mm and a lesion length of less than 26 mm.
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| Sample Size |
Number of subjects: 100
Assumptions for sample size estimation:
Number of sites: 20
Sites location: US and OUS
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| Key Study Endpoints |
Primary: Target lesion failure (TLF) at 1 year 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).
Secondary:
1. Device success, defined as attainment of < 30% residual stenosis of the target lesion (based on operator visual estimate) using the study device only. Note: Post-dilatation is allowed to achieve device success.
2. Procedure success, defined as attainment of < 30% residual stenosis of the target lesion (based on operator visual estimate) using the study device only without occurrence of in-hospital major adverse cardiovascular events (MACE; composite of all cause death, Q-wave or non-Q-wave MI and any clinically-driven TLR).
The following secondary endpoints will be evaluated at 6 months and 1, 2, 3, and 5 years post-index procedure:
3. All-cause death
4. Any MI
5. Cardiac death or MI
6. MACE and individual MACE components (MACE: composite of all-cause death, Q-wave or non–Q-wave MI, and any clinically driven TLR)
7. TLF (evaluated at 6 months, 2, 3 and 5 years) and individual TLF components (cardiac death, target vessel Q-wave or non–Qwave MI, and clinically-driven TLR)
8. Target vessel failure (TVF) and individual TVF components [TVF: composite of cardiac death, target vessel Q-wave or non-Q-wave MI, and clinically driven target vessel revascularization (CD-TVR)].
9. Target lesion revascularization (TLR)
10. Target vessel revascularization (TVR)
11. Stent thrombosis according to Academic Research Consortium – 2 (ARC-2) definition.
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| Follow-up Visits and Length of Follow-up |
Subjects will be followed for 5 years post-index procedure. Post-procedure follow-up intervals: 6 months and 1, 2, 3, and 5 years post-index procedure.
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