RecruitingNCT05698732

Coroflex® ISAR NEO PMCF Study

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

Sponsor

Fundación EPIC

Enrollment

3,000 participants

Start Date

Aug 4, 2023

Study Type

OBSERVATIONAL

Conditions

Coronary Artery Disease (CAD)Ischemic Heart Disease

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Coroflex® ISAR NEO coronary stent system for people with coronary artery disease (cad) and ischemic heart disease. The study is currently recruiting participants at 22 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECoroflex® ISAR NEO coronary stent system

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

Locations(22)

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 Regional Universitario de Málaga

Málaga, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Hospital Clinico Universitario Lozano Blesa

Zaragoza, Spain

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05698732

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