NAVISCORE PMCF Study ( rEPIC04F )

Fundación EPIC

Status: Completed

Conditions: Ischemic Heart Disease; Coronary Artery Disease

Treatments: Device: Naviscore

Study type: Observational

Funder types: Other

Identifiers

NCT05706805

NAVISCORE PMCF Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

54 participants in 1 patient group

Coronary Artery Disease (CAD)

Treatment:

Device: Naviscore