NAVISCORE PMCF Study ( rEPIC04F )
NCT05706805 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 54
Last updated 2024-02-06
Summary
Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Naviscore scoring balloon to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Naviscore.
Conditions
- Coronary Artery Disease
- Ischemic Heart Disease
Interventions
- DEVICE
-
Naviscore
Patients in whom treatment with (Naviscore) has been attempted
Sponsors & Collaborators
-
Fundación EPIC
lead OTHER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-31
- Primary Completion
- 2023-09-27
- Completion
- 2023-09-27
Countries
- Spain
Study Locations
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