Coroflex® ISAR NEO PMCF Study

Recruiting now

Conditions studied: Coronary Artery Disease (CAD), Ischemic Heart Disease

In brief

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.

Key facts

Study ID

NCT05698732

Run by

Fundación EPIC

People needed

3000

Starts

2023-08-04

Expected to finish

2027-02-01

Last updated by the study team

2026-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 Coronary Intervention (PCI) based on the last European Society of Cardiology (ESC) recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment AND
• Patients with Novo lesion length 2-4 mm AND
• Informed consent signed

You may not qualify if…

• 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 with Percutaneous transluminal Coronary Angioplasty (PTCA) or stent implantation
• Patients with known sensitivity to Sirolimus, the carrier Probucol, the procedural co-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

Where it is running

• Centre Hospitalier du Pays d'Aix — Aix-en-Provence, France (enrolling)
• Centre Hospitalier Ajaccio — Ajaccio, France (enrolling)
• CH Polyclinique Bordeaux Nord Aquitaine — Bordeaux, France (enrolling)
• University Hospital Center of Caen — Caen, France (enrolling)
• Hôpital Albert Schweitzer — Colmar, France (enrolling)
• Hospitalario Universitario (CHU) de Lille — Lille, France (enrolling)
• APHP -Hôpital Lariboisière — Paris, France (enrolling)
• Institut Arnault Tzanck — Saint-Laurent-du-Var, France (enrolling)
• Hospital Universitario A Coruña — A Coruña, Spain (enrolling)
• Hospital Universitario de Badajoz — Badajoz, Spain (enrolling)
• Hospital Universitari Germans Trias I Pujol — Badalona, Spain (enrolling)
• Hospital Universitario de Cruces — Barakaldo, Spain (enrolling)
• Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (enrolling)
• Hospital Universitari Vall D Hebron — Barcelona, Spain (enrolling)
• Hospital Universitario San Pedro de Alcantara — Cáceres, Spain (enrolling)
• Hospital General Universitario de Ciudad Real — Ciudad Real, Spain (enrolling)
• Hospital Universitario Juan Ramon Jimenez — Huelva, Spain (enrolling)
• Hospital Universitario de Leon — León, Spain (enrolling)
• Hospital Universitario Lucus Agusti — Lugo, Spain (enrolling)
• Hospital Regional Universitario de Málaga — Málaga, Spain (enrolling)
• Hospital Universitario Virgen de la Victoria — Málaga, Spain (enrolling)
• Hospital Clinico Universitario Lozano Blesa — Zaragoza, Spain (enrolling)

Full record on ClinicalTrials.gov

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