EXACT
Emboshield and Xact Post Approval Carotid Stent Trial
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Status:
Completed. First follow-up period of 30 days has been completed.
Purpose:
To collect clinical outcome and device performance data on the FDA 510(k)-cleared Emboshield® BareWire™ Rapid Exchange Embolic Protection System and FDA-approved Xact® Rapid Exchange Carotid Stent System to determine whether carotid stenting can be performed safely in the clinical setting by physicians with varying levels of experience.
Interventions:
Stent, carotid
Intravascular procedure to maintain carotid artery patency
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Year Started:
2005
Year Finished:
2007
Year Presented:
2007
Design:
Interventional, multi-centered, educational/counseling/training, non-randomized, open label, uncontrolled, single group assignment, safety study.
Inclusion Criteria
Subjects who are willing to have the Emboshield and/or the Xact inserted into the their vasculature.
Primary Outcome:
For all of the patients, 30-day composite of death, stroke and myocardial infarction (MI). For the 500 patients with 12-month follow-up a composite of stroke, death and MI at 30 days and ipsilateral stroke at 12 months (31-365 days).
Source of Information:
ClinicalTrials.gov
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Web Links and Publications:
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This information last updated on: 10/28/2007
Reviewed on: 05/20/2009.
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Trials
Directories