GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (EMBOLDEN)

Inclusion Criteria: 1. Subject is either: * Symptomatic (amaurosis fugax in the hemisphere supplied by the target vessel, TIA or non-disabling stroke within 6 months of the procedure) with carotid stenosis ≥50% as diagnosed by angiography using NASCET methodology, OR * Asymptomatic with carotid stenosis ≥80% as diagnosed by angiography using NASCET methodology 2. Target lesion is located in one of the following: * ICA * bifurcation * CCA proximal to the bifurcation 3. At Anatomic risk for adverse events from CEA (e.g., restenosis after a prior CEA) or at Co-morbid risk for adverse events from CEA (e.g., unstable angina with ECG changes) Exclusion Criteria: * Recent surgical procedure within 30 days before or after the stent procedure * Uncontrolled sensitivity to contrast media * Renal Insufficiency * Recent evolving, acute stroke within 21 days of study evaluation * Myocardial infarction within 72 hours prior to stent procedure * History of a prior major ipsilateral stroke with residual neurological deficits likely to confound the neurological assessments (e.g., NIHSS) * Neurological deficits not due to stroke likely to confound the neurological assessments (e.g., NIHSS) Angiographic Exclusion Criteria: * Isolated ipsilateral hemisphere leading to subject intolerance to reverse flow * Total occlusion of the ipsilateral carotid artery * Pre-existing stent in the ipsilateral carotid artery OR the contralateral carotid artery that extends into the aortic arch * Presence of a filling defect, thrombus, occlusion or "string sign" in the target vessel * Severe lesion calcification restricting stent deployment * Carotid stenosis located distal to target stenosis that is more severe than target stenosis * \>50% stenosis of the CCA proximal to target vessel * Known mobile plaque in the aortic arch