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RECRUITING
NCT05698732

Coroflex® ISAR NEO PMCF Study

Sponsor: Fundación EPIC

View on ClinicalTrials.gov

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.

Official title: Coroflex® ISAR NEO Coronary Stent System Post-Market Clinical Follow-up Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

3000

Start Date

2023-08-04

Completion Date

2027-02-01

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

DEVICE

Coroflex® ISAR NEO coronary stent system

Patients in whom treatment with Coroflex® ISAR NEO coronary stent system has been attempted

Locations (20)

Centre Hospitalier du Pays d'Aix

Aix-en-Provence, France

Centre Hospitalier Ajaccio

Ajaccio, France

CH Polyclinique Bordeaux Nord Aquitaine

Bordeaux, France

University Hospital Center of Caen

Caen, France

Hôpital Albert Schweitzer

Colmar, France

Hospitalario Universitario (CHU) de Lille

Lille, France

APHP -Hôpital Lariboisière

Paris, France

Institut Arnault Tzanck

Saint-Laurent-du-Var, France

Hospital Universitario A Coruña

A Coruña, Spain

Hospital Universitario de Badajoz

Badajoz, Spain

Hospital Universitari Germans Trias I Pujol

Badalona, Spain

Hospital Universitario de Cruces

Barakaldo, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Hospital Universitari Vall D Hebron

Barcelona, Spain

Hospital Universitario San Pedro de Alcantara

Cáceres, Spain

Hospital General Universitario de Ciudad Real

Ciudad Real, Spain

Hospital Universitario Juan Ramon Jimenez

Huelva, Spain

Hospital Universitario de Leon

León, Spain

Hospital Universitario Lucus Agusti

Lugo, Spain

Hospital Clinico Universitario Lozano Blesa

Zaragoza, Spain