Follows people with coronary artery disease treated with the Coroflex ISAR NEO stent
Observes patients with coronary artery disease who received the Coroflex ISAR NEO stent.
Plain-language title generated from the registry record
Registry title: Coroflex® ISAR NEO PMCF Study
Key facts
- Where
- Aix-en-Provence, Ajaccio, Bordeaux, Caen, Colmar, Lille, Paris, Rouen, Saint-Laurent-du-Var, and Toulouse, FranceSee the 10 sites
Where in France
- Centre Hospitalier du Pays d AIXAix-en-Provence, FranceTaking people
- Centre Hospitalier AjaccioAjaccio, FranceTaking people
- CH Polyclinique Bordeaux Nord AquitaineBordeaux, FranceTaking people
- University Hospital Center of CaenCaen, FranceTaking people
- Hôpital Albert SchweitzerColmar, FranceTaking people
- Hospitalario Universitario (CHU) de LilleLille, FranceTaking people
- Aphp-Hopital LariboisiereParis, FranceTaking people
- Clinique Saint-HilaireRouen, FranceTaking people
- Institut Arnault TzanckSaint-Laurent-du-Var, FranceTaking people
- Centre Hospitalier Universitaire (CHU) de ToulouseToulouse, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fundación EPIC
- Trial code
- NCT05698732
- Record updated
- 21 October 2026
- Original description
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.Read full original descriptionShow less
Coroflex® ISAR NEO Coronary Stent System Post-Market Clinical Follow-up Study
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.
Inclusion: 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: Patients with known sensitivity to Sirolimus, the carrier Probucol, the procedural co-medication or the alloying component of the stent; Patients with acute coronary syndrome (ACS) in a situation of cardiogenic shock (Killip 4); Patients with contraindications or hypersensitivity to sirolimus; Patients in whom anti-platelet and/or anti-coagulation therapy is contraindicated; 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.