Coroflex® ISAR NEO PMCF Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundación EPIC
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Coroflex® ISAR NEO coronary stent system
Treatment groups
3,000 Participants
are divided into 2 treatment groupsLocations
22France
Centre Hospitalier du Pays d'Aix13100, Aix-en-Provence France
Centre Hospitalier Ajaccio20090, Ajaccio France
CH Polyclinique Bordeaux Nord Aquitaine33300, Bordeaux France
University Hospital Center of Caen14000, Caen France
Sponsors and collaborators
Fundación EPIC
Lead sponsor
Source ClinicalTrials.gov