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Clinical Trials in France / NCT05698732
Recruiting Observational

Coroflex® ISAR NEO PMCF Study

NCT05698732 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2023-08-04
Last updated
2026-09-11

Condition(s) studied

Coronary Artery Disease (CAD)Ischemic Heart Disease

Investigational drug(s) / intervention(s)

Coroflex® ISAR NEO coronary stent system

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

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 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 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 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

Primary outcome measure(s)

Trial sites (26)

FacilityCityRegionStatus
Centre Hospitalier du Pays d'Aix Aix-en-Provence France Recruiting
Centre Hospitalier Ajaccio Ajaccio France Recruiting
CH Polyclinique Bordeaux Nord Aquitaine Bordeaux France Recruiting
University Hospital Center of Caen Caen France Recruiting
Hôpital Albert Schweitzer Colmar France Recruiting
Hospitalario Universitario (CHU) de Lille Lille France Recruiting
APHP -Hôpital Lariboisière Paris France Recruiting
Clinique Saint-Hilaire Rouen France Recruiting
Institut Arnault Tzanck Saint-Laurent-du-Var France Recruiting
Centre hospitalier universitaire (CHU) de Toulouse Toulouse France Recruiting
Hospital Universitario A Coruña A Coruña Spain Recruiting
Hospital Universitario de Badajoz Badajoz Spain Recruiting
Hospital Universitari Germans Trias I Pujol Badalona Spain Recruiting
Hospital Universitario de Cruces Barakaldo Spain Recruiting
Hospital de la Santa Creu i Sant Pau Barcelona Spain Recruiting
Hospital Universitari Vall D Hebron Barcelona Spain Recruiting
Hospital Universitario San Pedro de Alcantara Cáceres Spain Recruiting
Hospital General Universitario de Ciudad Real Ciudad Real Spain Recruiting
Hospital Universitario Juan Ramon Jimenez Huelva Spain Recruiting
Hospital Universitario de Leon León Spain Recruiting
Hospital Universitario Lucus Agusti Lugo Spain Recruiting
Hospital Regional Universitario de Málaga Málaga Spain Recruiting
Hospital Universitario Virgen de la Victoria Málaga Spain Recruiting
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain Recruiting
King's Mill Hospital, Sherwood Forest Hospitals Sutton in Ashfield United Kingdom Not Yet Recruiting
Royal Albert Edward Infirmary Wigan United Kingdom Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05698732 on ClinicalTrials.gov ↗ ← All trials in France