← Back to all trials
Not Yet Recruiting
NCT05698732
Coroflex® ISAR NEO PMCF Study y ( rEPIC07 )
Conditions: Coronary Artery Disease (CAD), Ischemic Heart Disease
Sex: All
Ages: 18 Years – N/A
Enrollment: 3000
Sponsor: Fundación EPIC
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 forPatients must be at least 18 years of age ANDThe 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 ANDPatients with Novo lesion length 2-4 mm ANDInformed consent signedExclusion 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 with contraindications or hypersensitivity to sirolimus.Patients with a life expectancy of less than 2 years.Patients included in other clinical trials.
Source: ClinicalTrials.gov (NCT05698732). StuddyBuddy aggregates publicly available trial information.