Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease (ACT I)

Exclusion criteria

• . Subject is symptomatic and has had a stroke or exhibited TIA (hemispheric or ocular) within 180 days prior to randomization, which has been confirmed by an independent study neurologist or independent study neurosurgeon.
• . Subject is participating in another drug or device trial (IND or IDE) that has not completed the primary endpoint or that may potentially confound the results of this trial. Subject may be enrolled only once in this trial and may not participate in any other clinical trial during a 1-year period post-index procedure.
• . Subject has inability to understand and cooperate with study procedures or provide informed consent.
• . Subject has had an intracranial hemorrhage or hemorrhagic stroke within 1-year prior the index procedure.
• . Subject has dementia or has a neurological illness that may confound the neurological evaluation.
• . Subject has had a known untoward reaction to anesthesia or contrast media not able to be overcome by pre-treatment with medications.
• . Subject has history of intolerance or allergic reaction to any of the study medications including aspirin, Clopidogrel bisulfate (Plavix®) or Ticlopidine (Ticlid®), heparin or Bivalirudin (Angiomax™). Subjects must be able to tolerate a combination of aspirin and Clopidogrel/Ticlopidine.
• . Subject has Hemoglobin (Hgb) less than 10 gm/dL, platelet count \<100,000/mm3 or \>500,000/mm3, or known heparin associated thrombocytopenia.