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Navitian PMCF Study ( rEPIC04C ) | Clinical Trials | Clareo Health

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COMPLETEDNCT05292118

Navitian PMCF Study ( rEPIC04C )

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) ...

Lead sponsor: Fundación EPIC•8 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Fundación EPIC

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-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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Patient treated with Navitian according to routine hospital practice and following instructions for use
•Informed consent signed

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 5, 2025Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment102

Start dateSep 2022

Last updatedMar 5, 2025

Condition

Coronary Artery Disease (CAD)Ischemic Heart Disease

Locations shown

Centro Hospitalar Vila Nova de Gaia

Vila Nova de Gaia

Hospital Universitari Vall D'Hebron

Barcelona

Hospital Clinic de Barcelona

Barcelona

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2025Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions