Inclusion Criteria- Subject is at high risk for carotid endarterectomy due to either anatomic or co-morbid conditions; AND
- Symptomatic patients (TIA or non-disabling stroke within 6 months of the procedure), with carotid stenosis ≥ 50% as diagnosed by angiography, using NASCET methodology (50); OR
- Asymptomatic patients with carotid stenosis ≥ 80% as diagnosed by angiography, using NASCET methodology
Exclusion Criteria- Conditions that interfere with the evaluation of endpoints
- Subject has anticipated or potential sources of cardiac emboli
- Subject plans to have a major surgical procedure within 30 days after the index procedure.
- Subject has intracranial pathology that makes the subject inappropriate for study participation.
- Subject has a total occlusion of the ipsilateral carotid artery (i.e., CCA).
- Severe circumferential lesion calcification that may restrict the full deployment of the carotid stent.
- Carotid stenosis located distal to the target stenosis that is more severe than the target stenosis.