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NAVISCORE PMCF Study ( rEPIC04F ) — rEPIC04F  

Coronary Artery Disease Clinical Trial

Official title:
NAVISCORE Post-Market Clinical Follow-up Study

Clinical Trial 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.

Clinical Trial 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 Naviscore scoring balloon in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05706805
Study type Observational
Source Fundación EPIC
Contact
Status Completed
Phase
Start date January 31, 2023
Completion date September 27, 2023
View Details
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