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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-01-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Carotid Artery Disease Carotid Stenosis Stroke Atherosclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Carotid artery stenting with filter (interventional)

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No