ClinicaliQ Trial Snapshot
- Coroflex® ISAR NEO PMCF Study — Recruiting • Cardiology / Cardiovascular • NCT05698732.
- Device being tested: The Coroflex® ISAR NEO coronary stent system is undergoing post-market clinical follow-up to verify its safety and performance profile in real-world clinical practice across multiple international centres, meeting EU Medical Device Regulation requirements.
- Patient eligibility: The study enrolls consecutive patients treated with the Coroflex® ISAR NEO stent across participating centres, representing an unselected, real-world patient population without restrictive inclusion/exclusion criteria typical of randomised trials.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.