Coroflex® ISAR NEO PMCF Study
NCT05698732 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000
Last updated 2026-05-01
Summary
International, Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Coroflex® ISAR NEO coronary stent system to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Coroflex® ISAR NEO coronary stent system sirolimus eluting stent.
Conditions
- Coronary Artery Disease (CAD)
- Ischemic Heart Disease
Interventions
- DEVICE
-
Coroflex® ISAR NEO coronary stent system
Patients in whom treatment with Coroflex® ISAR NEO coronary stent system has been attempted
Sponsors & Collaborators
-
Fundación EPIC
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-04
- Primary Completion
- 2027-02-01
- Completion
- 2027-02-01
Countries
- France
- Spain
Study Locations
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