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XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA Long Term Follow-up Cohort)

NCT01120379 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 5034

Last updated 2015-06-22

Study results available
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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.

Conditions

  • Chronic Coronary Occlusion
  • Vascular Disease
  • Myocardial Ischemia
  • Coronary Artery Stenosis
  • Coronary Disease
  • Coronary Artery Disease
  • Coronary Restenosis

Interventions

DEVICE

XIENCE V® EECSS

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

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • James Hermiller, MD · Heart Center of Indianapolis

  • Mitch Krucoff, MD · Duke University

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2011-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01120379 on ClinicalTrials.gov