Navitian PMCF Study ( rEPIC04C )

Completed

• Conditions: Coronary Artery Disease (CAD); Ischemic Heart Disease
• Interventions: Device: Navitian

• Registration Number: NCT05292118
• Lead Sponsor: Fundación EPIC

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) requirements in all the CONSECUTIVE patients treated with Navitian.

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-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 Timeline

• Study First Submitted: 2022-03-14
• Study First Submitted QC: 2022-03-14
• Study First Posted: 2022-03-23
• Study Start: 2022-09-26
• Primary Completion: 2024-07-11
• Study Completion: 2024-07-11
• Status Verified: 2024-08
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

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

Exclusion Criteria

• Not meet inclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary Artery Disease (CAD)	Navitian	-

Primary Outcome Measures

Name	Time	Method
Safety Endpoint. Freedom fromTarget Lesion Failure	7 days	Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).

Secondary Outcome Measures

Name	Time	Method
Efficacy Endpoint. Freedom from Target Lesion Failure	7 days	Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).
Freedom from Device rupture	During percutaneous coronary intervention (PCI)	Freedom from Device rupture
Freedom from Kinking	During PCI	Freedom from Kinking
Freedom from Coronary perforation	During PCI	Freedom from Coronary perforation
Freedom from Complicated withdrawal	During PCI	Freedom from Complicated withdrawal
Freedom from Coronary thrombosis	During PCI	Freedom from Coronary thrombosis
Freedom from Coronary dissection >C	During PCI	Freedom from Coronary dissection \>C
Freedom from No reflow	During PCI	Freedom from No reflow

Trial Locations

Locations (8)

Centro Hospitalar Vila Nova de Gaia; 🇵🇹 Vila Nova De Gaia, Portugal

Hospital Universitari Vall D'Hebron; 🇪🇸 Barcelona, Spain

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitario Juan Ramon Jimenez; 🇪🇸 Huelva, Spain

Hospital Universitario de Leon; 🇪🇸 León, Spain

Hospital Universitario Lucus Agusti; 🇪🇸 Lugo, Spain

Hospital Universitario Marques de Valdecilla; 🇪🇸 Santander, Spain

Hospital Clinico Universitario de Valladolid; 🇪🇸 Valladolid, Spain