SUPRAFLEX CRUZ PMCF Study ( rEpic05 )

Last updated: December 20, 2024
Sponsor: Fundación EPIC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Atherosclerosis

Heart Attack (Myocardial Infarction)

Treatment

SUPRAFLEX CRUZ

Clinical Study ID

NCT05617599
rEpic05 - Multiflex
  • 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 Medical Device Regulations (MDR) with multivessel coronary disease requirements in all the CONSECUTIVE patients treated with (SUPRAFLEX CRUZ).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥ 18 years old and;

  • Patients treated with SUPRAFLEX CRUZ according to routine hospital practice andfollowing instructions for use

  • Patients with multivessel coronary artery disease (understood as that which affectsmore than one territory of the major epicardial coronary arteries - anteriordescending, circumflex, right coronary artery) who is treated with more than 1 stentunder study in lesions located in more than 1 of the aforementioned arteries.

  • Substudy: Patients with Ejection Fraction <45% by Echocardiography

  • Informed consent signed

Exclusion

Exclusion Criteria:

  • Not meet inclusion criteria

  • Contraindication for antiplatelet treatment

  • Patient life expectancy less than 12 months

Study Design

Total Participants: 508
Treatment Group(s): 1
Primary Treatment: SUPRAFLEX CRUZ
Phase:
Study Start date:
May 10, 2023
Estimated Completion Date:
December 01, 2025

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 SUPRAFLEX CRUZ 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 General Universitario de Elche

    Elche, Alicante 03203
    Spain

    Active - Recruiting

  • Hospital Universitario de Cruces

    Barakaldo, 48903
    Spain

    Active - Recruiting

  • Hospital Universitari Vall D'Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08041
    Spain

    Active - Recruiting

  • Hospital General Universitario de Castellón

    Castelló, 12004
    Spain

    Active - Recruiting

  • Hospital General Universitario de Ciudad Real

    Ciudad Real, 13005
    Spain

    Active - Recruiting

  • Hospital Universitario A Coruña

    Coruña, 15006
    Spain

    Active - Recruiting

  • Hospital Universitario San Pedro de Alcántara

    Cáceres, 10003
    Spain

    Active - Recruiting

  • Hospital Universitari Dr. Josep Trueta

    Girona, 17007
    Spain

    Active - Recruiting

  • Hospital Universitario Clínico San Cecilio

    Granada, 18016
    Spain

    Active - Recruiting

  • Hospital Universitario de Leon

    León, 24001
    Spain

    Active - Recruiting

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25198
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario Virgen de la Arrixaca

    Murcia, 30120
    Spain

    Active - Recruiting

  • Hospital Parc Tauli

    Sabadell, 08208
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Santiago de Compostela

    Santiago de Compostela, 15706
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Universitario de Toledo

    Toledo, 45007
    Spain

    Active - Recruiting

  • Hospital Universitario Y Politécnico La Fé

    Valencia, 46026
    Spain

    Active - Recruiting

  • Hospital Universitario Lozano Blesa

    Zaragoza, 50009
    Spain

    Active - Recruiting

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