CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5,034 enrolled
Drug / intervention
XIENCE V® EECSSdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01120379
NCT01120379N/ACompleted
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XIENCE V® Everolimus Eluting Coronary Stent System (EECSS) USA Post-Approval Study (XIENCE V® USA Long Term Follow-up Cohort)

Abbott Medical Devices·observational·Posted May 10, 2010·Updated Jun 22, 2015

In Brief

An observational study evaluating XIENCE V® EECSS for Chronic Coronary Occlusion and 6 related conditions. Completed, enrolled 5,034 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

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Coronary Occlusion, Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease, Coronary Artery Disease, Coronary Restenosis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 10, 2010
Enrollment StartJul 1, 2008
Primary CompletionDec 1, 2011
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 16.1 years ago

Interventions

XIENCE V® EECSSdevice

Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.