Emboshield® and Xact® Post Approval Carotid Stent Trial (The EXACT Study)

Phase 4

Completed

• Conditions: Carotid Artery Disease; Carotid Stenosis; Stroke; Atherosclerosis

• Registration Number: NCT00287508
• Lead Sponsor: Abbott Medical Devices

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 System when used under commercial use conditions by a broad group of physicians entering the study with differing carotid artery stenting experiences.

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 carotid artery by ultrasound or angiogram (visual estimate), or

* Subjects without neurological symptoms and \>= 80% stenosis of the common or internal carotid artery by ultrasound or angiogram (visual estimate)

* The endpoint for the 1500 subjects enrolled will be a 30-day composite of death, stroke and myocardial infarction (MI).

* For the 500 subjects with 12 month follow-up, the endpoint will be a composite of stroke, death and MI at 30 days and ipsilateral stroke at 12 months (31-365 days).

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-02-01
• Study First Submitted QC: 2006-02-03
• Study First Posted: 2006-02-07
• Primary Completion: 2007-12
• Study Completion: 2008-01
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-16
• Last Update Posted: 2008-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• 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 Criteria

• There are no exclusion criteria for this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The endpoint for the 1500 subjects enrolled will be a 30-day composite of death, stroke and myocardial infarction (MI).
For the 500 subjects with 12 month follow-up, the endpoint will be a composite of stroke, death and MI at 30 days and ipsilateral stroke at 12 months (31-365 days).