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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
1,500
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).
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