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

Sponsor

Abbott Medical Devices (Industry)

Overall Status

Completed

CT.gov ID

NCT00287508

Collaborator

(none)

1,500

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Disease Carotid Stenosis Stroke Atherosclerosis	Device: Carotid artery stenting with filter (interventional)	Phase 4

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 Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

Emboshield and Xact Post Approval Carotid Stent Trial Using the Emboshield® BareWire™ Rapid Exchange Embolic Protection System and Xact® Rapid Exchange Carotid Stent System

Study Start Date :

Nov 1, 2005

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Jan 1, 2008

Outcome Measures

Primary Outcome Measures

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). []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.