Postapproval Trial On Carotid Stenting in Patients With High Risk Vs Standard Risk for Open Carotid Endarterectomy(REAL)

Inclusion criteria

• Symptomatic patients who have a transient ischemic attack, amaurosis fugax, or minor nondisabling stroke in the distribution of the study artery within 180 days of inclusion and have been shown carotid artery stenosis ≥50% by angiography, ≥70% by ultrasound, or ≥70% by CT angiography or MR angiography if ultrasound is 50% to 69%
• Asymptomatic patients who have carotid artery stenosis of ≥60% by angiography, ≥70% by ultrasound, or ≥80% by CT angiography or MR angiography if ultrasound is 50% to 69%

Exclusion criteria

• Patient is unable to respond to external questions and stimuli and to exert a pressure with the contralateral hand
• Patient has an myocardial infarction within 72 hours prior to carotid stenting
• Patient has a major residual neurological deficit (stroke scales: Barthel ≤ 60, NIH ≥ 15 or Rankin >3) at pre-procedure neurological exam
• Patient had a transient ischemic attack (TIA) or amaurosis fugax within 48 hours prior to index procedure
• Patient had a stroke or retinal artery occlusion within 1 month prior to index procedure
• Patient has severe chronic renal failure (creatinine > 2.5mg/dL)
• The target carotid artery is completely occluded
• The common carotid artery ostium has stenosis that required treatment
• The presence of ipsilateral intracranial stenosis that requires treatment
• The inability to position a stiff 0.035" guidewire in the external carotid artery
• Contralateral occlusion of internal carotid artery and vertebral arteries