Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) (PROTECT)

Exclusion Criteria

• •The subject is participating in another investigational trial that would interfere with the conduct or result of this study.
• •The subject has dementia or a neurological illness that may confound the neurological evaluation.
• •Total occlusion of the target vessel.
• •There is an existing, previously placed stent in the target artery.
• •The subject has a known life-threatening allergy to the contrast media that cannot be treated.
• •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 or aspirin and Ticlopidine.
• •The subject has a GI bleed that would interfere with antiplatelet therapy.
• •The subject has known cardiac sources of emboli, including but not limited to current or past history of paroxysmal or sustained atrial fibrillation (treated or untreated), valve replacement, etc.
• •Subject has Hemoglobin (Hgb) less than 8 gm/dL (unless on dialysis), platelet count \<50,000/mm3, or known heparin associated thrombocytopenia.
• •The subject has a history of bleeding diathesis or coagulopathy including thrombocytopenia or an inability to receive heparin or Bivalirudin (Angiomax™) in amounts sufficient to maintain an ACT of \>250, or will refuse blood transfusion.
• •The subject has atherosclerotic disease involving adjoining vessels that precludes safe placement of the guiding catheter or sheath.
• •The subject has other abnormal angiographic findings that indicate the subject is at risk for a stroke due to a problem other than that of the target lesion, such as: ipsilateral arterial stenosis greater in severity than the target lesion, cerebral aneurysm, or arteriovenous malformation of the cerebral vasculature.
• •There is evidence of a carotid artery dissection prior to the initiation of the index procedure.
• •There is an angiographically visible thrombus.
• •There is any condition that precludes proper angiographic assessment, placement of the cerebral protective system or makes percutaneous arterial access unsafe, e.g. morbid obesity, sustained systolic blood pressure \>180 mm Hg, tortuosity, occlusive disease, vessel anatomy, or aortic arch anatomy.
• •Occlusion (TIMI 0 flow), or string sign of the ipsilateral common or internal carotid artery.
• •There is evidence of bilateral carotid stenosis that would require intervention within 30 days of the index procedure.
• •There is evidence of a stroke within the previous 30 days of the index procedure.
• •There is a planned treatment of a non-target lesion within 30 days post-index procedure.
• •There is a history of intracranial hemorrhage within the previous 3 months, including hemorrhagic transformation of an ischemic stroke.
• •There is a history of an ipsilateral stroke with fluctuating neurologic symptoms within one year of the index procedure.