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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.
This is a multi-center, observational, single arm, post-approval study enrolling the following study population:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carotid artery stenting with filter (interventional) | Device |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Don E Schwarten, MD | Abbott Medical Devices | Study Chair |
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| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D016893 | Carotid Stenosis |
| D020521 | Stroke |
| D050197 | Atherosclerosis |
| D002544 | Cerebral Infarction |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001157 | Arterial Occlusive Diseases |
| D001161 | Arteriosclerosis |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |