NAVISCORE PMCF Study ( rEPIC04F )

Completed

• Conditions: Ischemic Heart Disease; Coronary Artery Disease
• Interventions: Device: Naviscore

• Registration Number: NCT05706805
• 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 Naviscore scoring balloon to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Naviscore.

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 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 Timeline

• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2023-01-30
• Study Start: 2023-01-31
• Study First Posted: 2023-01-31
• Primary Completion: 2023-09-27
• Study Completion: 2023-09-27
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-03
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Patient treated with Naviscore 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)	Naviscore	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Efficacy Endpoint. Freedom from Target Lesion Failure (TLF)	7 days	Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).
Freedom from Coronary perforation	During PCI (Percutaneous Coronary Intervention)	Freedom from Coronary perforation according to the modified Ellis classification
Freedom from Hypotube rupture	During PCI (Percutaneous Coronary Intervention)	Freedom from Hypotube rupture ( partial or total fracture of the shaft of the device)
Freedom from Complicated withdrawal	During PCI (Percutaneous Coronary Intervention)	Freedom from Complicated withdrawal (difficult or impossible device retrieval that may or may not cause clinical complications)
Freedom from Balloon rupture	During PCI (Percutaneous Coronary Intervention)	Freedom from Balloon rupture
Freedom from Coronary dissection >C	During PCI (Percutaneous Coronary Intervention)	Freedom from Coronary dissection \>C according to the NHLBI Classification (National Heart, Lung, and Blood Institute)
Freedom from Coronary thrombosis	During PCI (Percutaneous Coronary Intervention)	Freedom from Coronary thrombosis according to ARC-2 ( Academic Research Consortium-2) criteria
Freedom from No reflow	During PCI (Percutaneous Coronary Intervention)	Freedom from No reflow (persistently slowed flow with residual stenosis \<30% and no flow-limiting dissection)

Trial Locations

Locations (7)

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

Hospital Universitario de Leon; 🇪🇸 León, Spain

Hospital Universitario de Cáceres; 🇪🇸 Cáceres, Spain

Hospital Universitario Lucus Agusti; 🇪🇸 Lugo, Spain

Hospital Regional Universitario Carlos Haya; 🇪🇸 Málaga, Spain

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitario Juan Ramon Jimenez; 🇪🇸 Huelva, Spain