NCT05698732Recruiting
Coroflex® ISAR NEO PMCF Study
Coroflex® ISAR NEO Coronary Stent System Post-Market Clinical Follow-up Study
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 16 Jan 2023
- Start date
- 4 Aug 2023
- Primary completion date
- 1 Feb 2027
- Lead sponsor
- Fundación EPIC
- Diseases
- Coronary artery disease
- NCT number
- NCT05698732
What you commit to
- Study type: Observational
- Planned participants: 3000
- From 4 Aug 2023 to the primary completion date, 1 Feb 2027
- 26 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with known sensitivity to Sirolimus, the carrier Probucol, the procedural co-medication or the alloying component of the stent
Other illness
- Patients with acute coronary syndrome (ACS) in a situation of cardiogenic shock (Killip 4).
- Patients with contraindications or hypersensitivity to sirolimus
Lab values
- Patients in whom anti-platelet and/or anti-coagulation therapy is contraindicated
Other
- Patients with express refusal by the patient to participate in the study.
- Patients pregnant women and lactating women.
- Patients with lesions, that possibly can not be treated successfully with Percutaneous transluminal Coronary Angioplasty (PTCA) or stent implantation
- Patients with known sensitivity to contrast agents who cannot be premedicated.
- Patients with a life expectancy of less than 2 years
- Patients included in other clinical trials
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Recruiting |
| Hospital Universitario de Badajoz Coordinator of this site? Confirm its status | Badajoz | Spain | Recruiting |
| Hospital Universitari Germans Trias i Pujol Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hospital Universitario de Cruces Coordinator of this site? Confirm its status | Barakaldo | Spain | Recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario San Pedro de Alcántara Coordinator of this site? Confirm its status | Cáceres | Spain | Recruiting |
| Hospital General Universitario de Ciudad Real Coordinator of this site? Confirm its status | Ciudad Real | Spain | Recruiting |
| Hospital Universitario Juan Ramon Jimenez Coordinator of this site? Confirm its status | Huelva | Spain | Recruiting |
| Hospital Universitario De Leon Coordinator of this site? Confirm its status | León | Spain | Recruiting |
| Hospital Universitario Lucus Agusti Coordinator of this site? Confirm its status | Lugo | Spain | Recruiting |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Hospital Regional Universitario de Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
| Centre Hospitalier du Pays d AIX Coordinator of this site? Confirm its status | Aix-en-Provence | France | Recruiting |
| Centre Hospitalier Ajaccio Coordinator of this site? Confirm its status | Ajaccio | France | Recruiting |
| CH Polyclinique Bordeaux Nord Aquitaine Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| University Hospital Center of Caen Coordinator of this site? Confirm its status | Caen | France | Recruiting |
| Hôpital Albert Schweitzer Coordinator of this site? Confirm its status | Colmar | France | Recruiting |
| Hospitalario Universitario (CHU) de Lille Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Aphp-Hopital Lariboisiere Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Clinique Saint-Hilaire Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
| Institut Arnault Tzanck Coordinator of this site? Confirm its status | Saint-Laurent-du-Var | France | Recruiting |
| Centre Hospitalier Universitaire (CHU) de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Recruiting |
| King's Mill Hospital, Sherwood Forest Hospitals Coordinator of this site? Confirm its status | Sutton in Ashfield | United Kingdom | Recruiting |
| Royal Albert Edward Infirmary Coordinator of this site? Confirm its status | Wigan | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.