XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA-Phase 1)

Completed

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT00676520

Run by

Abbott Medical Devices

People needed

8053

Starts

2008-07-01

Expected to finish

2011-03-01

Last updated by the study team

2012-11-20

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient agrees to participate in this study by signing the Institutional Review Board approved informed consent form.

You may not qualify if…

• The inability to obtain an informed consent.
• Age limit is determined by investigator.
• There are no angiographic inclusion or exclusion criteria for this study.

Where it is running

• Abbott Vascular — Santa Clara, California, United States

Full record on ClinicalTrials.gov

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