Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy

Inclusion criteria

• Subject must be ≥ 18 years of age.
• Subject does not have any condition that limits their anticipated survival to less than 3 years.
• Subject or a legally authorized representative must provide written informed consent prior to any trial related procedure.
• Subjects with neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 50% stenosis of the common or internal carotid artery by angiogram - OR-
• Subjects without neurological symptoms within 180 days of the procedure and ≥ 70% stenosis of the common or internal carotid artery by ultrasound or ≥ 60% stenosis of the common or internal carotid artery by angiogram.
• Subject with all the following target vessel characteristics:

• Discrete lesion in internal carotid artery (ICA) with or without involvement of the contiguous common carotid artery (CCA).
• Vessel diameter ≥ 4.0 mm and ≤ 9.0 mm from reference or contralateral artery.
• Absence of excessive vessel tortuosity that would impede delivery of devices.
• Subject must agree not to participate in any other clinical trial for a period of 1 year following the index procedure.

Exclusion criteria

• Subjects with anatomic or clinical conditions which make them at high risk for adverse events from carotid endarterectomy (CEA).
• Subject with Hgb <10.g/dl or platelet count < 125,000 µl or has heparin-associated thrombocytopenia. For subjects on Coumadin (Warfarin) and for subjects with a platelet or coagulation disorder: Has an international normalized ratio (INR) > 1.5.
• Subject has active bleeding diathesis or coagulopathy or subject would refuse blood transfusions.
• Subject is currently on a list for major organ transplantation (i.e., heart, lung, liver, kidney) or is being evaluated for such.
• Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
• Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.