NAVISCORE PMCF Study ( rEPIC04F )

Fundación EPIC54 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Coronary Artery Disease Ischemic Heart Disease

Interventions

NaviscoreDEVICE

Patients in whom treatment with (Naviscore) has been attempted

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Hospital Universitari Vall D'Hebron

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Universitario de Cáceres

Cáceres, Spain

Hospital Universitario Juan Ramon Jimenez

Huelva, Spain

Outcomes

Primary Outcomes

Safety Endpoint. Freedom from Target Lesion Failure

Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR).

Time frame: 7 days

Secondary Outcomes

Efficacy Endpoint. Freedom from Target Lesion Failure (TLF)

Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).

Time frame: 7 days

Freedom from Balloon rupture