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Recruiting NCT05698732

Coroflex® ISAR NEO PMCF Study

Conditions: Coronary Artery Disease (CAD), Ischemic Heart Disease

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 3000
Sponsor: Fundación EPIC

Location: Centre Hospitalier du Pays d'Aix Aix-en-Provence

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 known sensitivity to Sirolimus, the carrier Probucol, the procedural co-medication or the alloying component of the stent * Patients with known sensitivity to contrast agents who cannot be premedicated. * Patients with contraindications or hypersensitivity to sirolimus * Patients with a life expectancy of less than 2 years * Patients included in other clinical trials

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05698732). StuddyBuddy aggregates publicly available trial information.