Actively Recruiting
Coroflex® ISAR NEO PMCF Study
Led by Fundación EPIC · Updated on 2026-05-01
3000
Participants Needed
22
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Coroflex® ISAR NEO PMCF Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be at least 18 years of age
- Patients must meet the standard recommendations for Percutaneous Coronary Intervention (PCI) according to the latest European Society of Cardiology (ESC) guidelines or have the use of the product already planned as part of regular treatment
- Patients must have a new lesion length between 2 and 4 millimeters
- Signed informed consent
You will not qualify if you...
- Patients who refuse to participate in the study
- Pregnant or breastfeeding women
- Patients with acute coronary syndrome in cardiogenic shock (Killip 4)
- Patients for whom anti-platelet or anti-coagulation therapy is contraindicated
- Patients with lesions unlikely to be successfully treated with Percutaneous Transluminal Coronary Angioplasty (PTCA) or stent implantation
- Patients with known sensitivity to sirolimus, probucol, procedural co-medications, or stent alloy components
- Patients with known sensitivity to contrast agents who cannot be premedicated
- Patients with contraindications or hypersensitivity to sirolimus
- Patients with life expectancy less than 2 years
- Patients currently enrolled in other clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
Centre Hospitalier du Pays d'Aix
Aix-en-Provence, France, 13100
Actively Recruiting
2
Centre Hospitalier Ajaccio
Ajaccio, France, 20090
Actively Recruiting
3
CH Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, 33300
Actively Recruiting
4
University Hospital Center of Caen
Caen, France, 14000
Actively Recruiting
5
Hôpital Albert Schweitzer
Colmar, France
Actively Recruiting
6
Hospitalario Universitario (CHU) de Lille
Lille, France, 59000
Actively Recruiting
7
APHP -Hôpital Lariboisière
Paris, France, 75010
Actively Recruiting
8
Institut Arnault Tzanck
Saint-Laurent-du-Var, France, 06700
Actively Recruiting
9
Hospital Universitario A Coruña
A Coruña, Spain, 15006
Actively Recruiting
10
Hospital Universitario de Badajoz
Badajoz, Spain, 06080
Actively Recruiting
11
Hospital Universitari Germans Trias I Pujol
Badalona, Spain, 08916
Actively Recruiting
12
Hospital Universitario de Cruces
Barakaldo, Spain, 48903
Actively Recruiting
13
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Actively Recruiting
14
Hospital Universitari Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
15
Hospital Universitario San Pedro de Alcantara
Cáceres, Spain, 10003
Actively Recruiting
16
Hospital General Universitario de Ciudad Real
Ciudad Real, Spain, 13005
Actively Recruiting
17
Hospital Universitario Juan Ramon Jimenez
Huelva, Spain, 21005
Actively Recruiting
18
Hospital Universitario de Leon
León, Spain, 24071
Actively Recruiting
19
Hospital Universitario Lucus Agusti
Lugo, Spain, 27003
Actively Recruiting
20
Hospital Regional Universitario de Málaga
Málaga, Spain, 29010
Actively Recruiting
21
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Actively Recruiting
22
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Spain, 50009
Actively Recruiting
Research Team
K
koldobika García San Román, MD, PhD
CONTACT
F
FUNDACION EPIC
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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