SAPPHIRE Worldwide: Stenting and Angioplasty With Protection in Patients At High-Risk for Endarterectomy

Inclusion Criteria: * High-surgical risk patients to be treated consistent with IFU labeling * The patient or legally authorized representative has signed a written informed consent and HIPAA authorization, prior to the procedure, using a form that is approved by the Institutional Review Board or Medical Ethics Committee. Exclusion Criteria: * Patients not treated per the IFU * Patients who are contraindicated per the IFU * Patients previously enrolled in the study * Patients requiring stenting of in-stent restenosis after CAS * Inability or refusal to provide informed consent.