Coroflex® ISAR NEO PMCF Study

Last updated: May 18, 2025
Sponsor: Fundación EPIC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thrombosis

Angina

Heart Attack (Myocardial Infarction)

Treatment

Coroflex® ISAR NEO coronary stent system

Clinical Study ID

NCT05698732
Coroflex® ISAR NEO PMCF Study
  • Ages > 18
  • All Genders

Study Summary

International, Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Coroflex® ISAR NEO coronary stent system to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Coroflex® ISAR NEO coronary stent system sirolimus eluting stent.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Coroflex® ISAR NEO is intended to be used for

  • Patients must be at least 18 years of age AND

  • The patient must fulfill the standard recommendations for Percutaneous CoronaryIntervention (PCI) based on the last European Society of Cardiology (ESC)recommendations within his/ her regular treatment or that the use of the product hasalready been decided within the regular planning of the patient's treatment AND

  • Patients with Novo lesion length 2-4 mm AND

  • Informed consent signed

Exclusion

Exclusion Criteria:

  • Patients with express refusal by the patient to participate in the study.

  • Patients pregnant women and lactating women.

  • Patients with acute coronary syndrome (ACS) in a situation of cardiogenic shock (Killip 4).

  • Patients with contraindications or hypersensitivity to sirolimus.

  • Patients with a life expectancy of less than 2 years.

  • Patients included in other clinical trials.

Study Design

Total Participants: 3000
Treatment Group(s): 1
Primary Treatment: Coroflex® ISAR NEO coronary stent system
Phase:
Study Start date:
August 04, 2023
Estimated Completion Date:
February 01, 2027

Study Description

The objective of this international, multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Coroflex® ISAR NEO coronary stent system Sirolimus Eluting Stent 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 Universitario de Badajoz

    Badajoz, 06080
    Spain

    Active - Recruiting

  • Hospital Universitari Germans Trias I Pujol

    Badalona, 08916
    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, 08025
    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 Alcantara

    Cáceres, 10003
    Spain

    Active - Recruiting

  • Hospital Universitario Juan Ramon Jimenez

    Huelva, 21005
    Spain

    Active - Recruiting

  • Hospital Universitario de Leon

    León, 24071
    Spain

    Active - Recruiting

  • Hospital Universitario Lucus Agusti

    Lugo, 27003
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009
    Spain

    Active - Recruiting

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