Stroke Clinical Trial
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
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).
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
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