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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
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