← Back to Clinical Trials
Recruiting NCT05698732

Coroflex® ISAR NEO PMCF Study

Trial Parameters

Condition Coronary Artery Disease (CAD)
Sponsor Fundación EPIC
Study Type OBSERVATIONAL
Phase N/A
Enrollment 3,000
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-08-04
Completion 2027-02-01
Interventions
Coroflex® ISAR NEO coronary stent system

Brief Summary

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

Inclusion Criteria: 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 Criteria: * 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 * Patients with lesions, that possibly can not be treated successfully with Percutaneous transluminal Coronary Angioplasty (PTCA) or stent implantation * Patients with know

Related Trials