Coroflex® ISAR NEO PMCF Study

Last updated: April 30, 2026
Sponsor: Fundación EPIC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cardiac Disease

Hypercholesterolemia

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 in whom anti-platelet and/or anti-coagulation therapy is contraindicated

  • Patients with lesions, that possibly can not be treated successfully withPercutaneous transluminal Coronary Angioplasty (PTCA) or stent implantation

  • Patients with known sensitivity to Sirolimus, the carrier Probucol, the proceduralco-medication or the alloying component of the stent

  • Patients with known sensitivity to contrast agents who cannot be premedicated.

  • 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

  • Centre Hospitalier du Pays d'Aix

    Aix-en-Provence, 13100
    France

    Active - Recruiting

  • Centre Hospitalier du Pays d'Aix

    Aix-en-Provence 3038354, 13100
    France

    Site Not Available

  • Centre Hospitalier Ajaccio

    Ajaccio, 20090
    France

    Active - Recruiting

  • Centre Hospitalier Ajaccio

    Ajaccio 3038334, 20090
    France

    Site Not Available

  • CH Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300
    France

    Active - Recruiting

  • CH Polyclinique Bordeaux Nord Aquitaine

    Bordeaux 3031582, 33300
    France

    Site Not Available

  • University Hospital Center of Caen

    Caen, 14000
    France

    Active - Recruiting

  • University Hospital Center of Caen

    Caen 3029241, 14000
    France

    Site Not Available

  • Hôpital Albert Schweitzer

    Colmar,
    France

    Active - Recruiting

  • Hôpital Albert Schweitzer

    Colmar 3024297,
    France

    Site Not Available

  • Hospitalario Universitario (CHU) de Lille

    Lille, 59000
    France

    Active - Recruiting

  • Hospitalario Universitario (CHU) de Lille

    Lille 2998324, 59000
    France

    Site Not Available

  • APHP -Hôpital Lariboisière

    Paris, 75010
    France

    Active - Recruiting

  • APHP -Hôpital Lariboisière

    Paris 2988507, 75010
    France

    Site Not Available

  • Institut Arnault Tzanck

    Saint-Laurent-du-Var, 06700
    France

    Active - Recruiting

  • Institut Arnault Tzanck

    Saint-Laurent-du-Var 2978891, 06700
    France

    Site Not Available

  • Hospital Universitario A Coruña

    A Coruña, 15006
    Spain

    Active - Recruiting

  • Hospital Universitario A Coruña

    A Coruña 3119841, 15006
    Spain

    Site Not Available

  • Hospital Universitario de Badajoz

    Badajoz, 06080
    Spain

    Active - Recruiting

  • Hospital Universitario de Badajoz

    Badajoz 2521420, 06080
    Spain

    Site Not Available

  • Hospital Universitari Germans Trias I Pujol

    Badalona, 08916
    Spain

    Active - Recruiting

  • Hospital Universitari Germans Trias I Pujol

    Badalona 3129028, 08916
    Spain

    Site Not Available

  • Hospital Universitario de Cruces

    Barakaldo, 48903
    Spain

    Active - Recruiting

  • Hospital Universitario de Cruces

    Barakaldo 3109453, 48903
    Spain

    Site Not Available

  • Hospital Universitari Vall D Hebron

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025
    Spain

    Active - Recruiting

  • Hospital Universitari Vall D Hebron

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona 3128760, 08025
    Spain

    Site Not Available

  • Hospital General Universitario de Ciudad Real

    Ciudad Real, 13005
    Spain

    Active - Recruiting

  • Hospital General Universitario de Ciudad Real

    Ciudad Real 2519402, 13005
    Spain

    Site Not Available

  • Hospital Universitario A Coruña

    Coruña, 15006
    Spain

    Site Not Available

  • Hospital Universitario San Pedro de Alcantara

    Cáceres, 10003
    Spain

    Active - Recruiting

  • Hospital Universitario San Pedro de Alcantara

    Cáceres 2520611, 10003
    Spain

    Site Not Available

  • Hospital Universitario Juan Ramon Jimenez

    Huelva, 21005
    Spain

    Active - Recruiting

  • Hospital Universitario Juan Ramon Jimenez

    Huelva 2516548, 21005
    Spain

    Site Not Available

  • Hospital Universitario de Leon

    León, 24071
    Spain

    Active - Recruiting

  • Hospital Universitario de Leon

    León 3118532, 24071
    Spain

    Site Not Available

  • Hospital Universitario Lucus Agusti

    Lugo, 27003
    Spain

    Active - Recruiting

  • Hospital Universitario Lucus Agusti

    Lugo 3117814, 27003
    Spain

    Site Not Available

  • Hospital Regional Universitario de Málaga

    Málaga, 29010
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza 3104324, 50009
    Spain

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.