Status:
COMPLETED
Navitian PMCF Study ( rEPIC04C )
Lead Sponsor:
Fundación EPIC
Conditions:
Coronary Artery Disease (CAD)
Ischemic Heart Disease
Eligibility:
All Genders
18+ years
Brief Summary
Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Navitian to meet EU Medical Device regulation (MDR) ...
Detailed Description
The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Navitian in a NON-SELEC...
Eligibility Criteria
Inclusion
- Patient treated with Navitian according to routine hospital practice and following instructions for use
- Informed consent signed
Exclusion
- Not meet inclusion criteria
Key Trial Info
Start Date :
September 26 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 11 2024
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT05292118
Start Date
September 26 2022
End Date
July 11 2024
Last Update
March 5 2025
Active Locations (8)
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1
Centro Hospitalar Vila Nova de Gaia
Vila Nova de Gaia, Portugal, 4434-502
2
Hospital Universitari Vall D'Hebron
Barcelona, Spain, 08035
3
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
4
Hospital Universitario Juan Ramon Jimenez
Huelva, Spain, 21005