Status:
COMPLETED
Emboshield® and Xact® Post Approval Carotid Stent Trial (The EXACT Study)
Lead Sponsor:
Abbott Medical Devices
Conditions:
Carotid Artery Disease
Carotid Stenosis
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
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 Sys...
Detailed Description
This is a multi-center, observational, single arm, post-approval study enrolling the following study population: * Subjects with neurological symptoms and \>= 50% stenosis of the common or internal c...
Eligibility Criteria
Inclusion
- Subjects who agree to participate in this study and have signed the IRB approved informed consent form.
- Subjects who are willing to have the Emboshield and/or the Xact inserted into the their vasculature.
Exclusion
- There are no exclusion criteria for this study.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2008
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT00287508
Start Date
November 1 2005
End Date
January 1 2008
Last Update
October 17 2008
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