Abstract
1 min readBackground: The ABSORB Cohort A trial results demonstrated the safety of the ABSORB bioresorbable vascular scaffold in 30 patients with single de novo native coronary artery lesions, with a low long-term MACE rate at 4 years of 3.4% and no scaffold thrombosis. Methods: The ABSORB Clinical Investigation enrolled 30 patients (Cohort A) in clinical sites in the European and Asia Pacific regions. The purpose of the ABSORB Clinical Investigation is to assess the safety and performance of the ABSORB Everolimus Eluting Vascular Scaffold (Abbott Vascular, Santa Clara, CA, USA) in the treatment of patients with a single de novo native coronary artery lesion. Key endpoints include ischemia driven major adverse cardiac events (ID-MACE) and its components out to 5 years with angiographic and IVUS endpoints at 6 months and 2 years and Multi-slice Spiral Computed Tomography (MSCT) imaging at 18 months. The ABSORB protocol was amended in the 4 sites who enrolled patients in Cohort A to add an optional additional MSCT im...
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