At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) USA Post-Approval Study
In Brief
An observational study evaluating XIENCE V® Everolimus Eluting Coronary Stent for Coronary Artery Disease. Completed, enrolled 8,053 participants across 1 site.
Detailed Summary
XIENCE V USA is a prospective, multi-center, multi-cohort post-approval study. The objectives of this study are * To evaluate XIENCE V EECSS continued safety and effectiveness during commercial use in real world settings, and * To support the Food and Drug Administration (FDA) dual antiplatelet therapy (DAPT) initiative. This initiative is designed to evaluate the composite of all death, myocardial infarction (MI) and stroke (MACCE) and the survival of patients that are free from Academic Research Consortium (ARC) definite or probable stent thrombosis (ST) and that have been treated with drug eluting stents (DES) and extended dual antiplatelet therapy.
Study Details
Timeline
Interventions
Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.