NAVISCORE PMCF Study ( rEPIC04F )

Last updated: February 3, 2024
Sponsor: Fundación EPIC
Overall Status: Completed

Phase

N/A

Condition

Atherosclerosis

Heart Disease

Coronary Artery Disease

Treatment

Naviscore

Clinical Study ID

NCT05706805
NAVISCORE PMCF Study
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient treated with Naviscore according to routine hospital practice and followinginstructions for use
  • Informed consent signed

Exclusion

Exclusion Criteria:

• Not meet inclusion criteria

Study Design

Total Participants: 54
Treatment Group(s): 1
Primary Treatment: Naviscore
Phase:
Study Start date:
January 31, 2023
Estimated Completion Date:
September 27, 2023

Study 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.

Connect with a study center

  • Hospital Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Universitari Vall D'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario de Cáceres

    Cáceres, 10003
    Spain

    Site Not Available

  • Hospital Universitario Juan Ramon Jimenez

    Huelva, 21005
    Spain

    Site Not Available

  • Hospital Universitario de Leon

    León, 24008
    Spain

    Site Not Available

  • Hospital Universitario Lucus Agusti

    Lugo, 27003
    Spain

    Site Not Available

  • Hospital Regional Universitario Carlos Haya

    Málaga, 29010
    Spain

    Site Not Available

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