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Biofreedom Stent in All Comer Population

University of Roma La Sapienza · 2016
ClinicalTrials.gov · Datasets · License: Public Domain · 2016
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coronary-artery-disease
AIM OF THE STUDY: The aim of the present registry is to investigate the procedural as well as the long-term clinical results in terms of safety and efficacy of the polymer-free DES technology in all comers patients with an indication to percutaneous coronary intervention. PRIMARY SAFETY ENDPOINTS: the cumulative hierarchical incidence of major adverse cardiac events (MACCE) defined as: cardiac death, non-fatal myocardial infarction (MI), stroke and ARC-defined stent thrombosis (18) at any time point and bleeding defined according to BARC classification (19). PRIMARY EFFICACY ENDPOINTS: clinically driven target lesion revascularization (TLR). STUDY DESIGN: multicenter (presumably 10 centers across the Italian territory), prospective observational registry aiming to enroll a population of 1000 patients. STUDY DURATION: We project 12 months for recruitment, 5 year follow-up duration after last patient in the registry. CLINICAL FOLLOW-UP PLAN: 30 days, 3, 6, 9 months, 1 year, and then yearly up to 5 years after the index procedure. PATIENTS SELECTION CRITERIA: This is an "all comers" registry and patient who will be enrolled have to meet the sequent criteria: * Patient must be at least 18 years of age at the time of signing the Informed Consent Form after Biofreedom placement. * All "de novo" lesion subsets are included. * Patient must agree to undergo all required follow-up visits and data collection. * Patient must have indication to percutaneous coronary intervention following: * Stable angina or evidence of myocardial ischemia with stress echocardiography/ myocardial SPECT/exercise test, or * Unstable angina / non ST-elevation myocardial infarction * ST-elevation myocardial infarction with de novo culprit lesion. EXCLUSION CRITERIA: The exclusion criteria must follow the most recent IFU which may include but are not limited to the following: * Known intolerance to any of the device components * In-stent restenosis * Woman with childbearing potentia
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