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