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|Summary of Trial: ||A randomized trial to demonstrate the non-inferiority of carotid artery stenting (CAS), using the Emboshield® Embolic Protection System with the Xact® Carotid Stent System, to carotid endarterectomy (CEA) for the treatment of asymptomatic extracranial carotid atherosclerotic disease in subjects considered at standard risk for adverse events from CEA.|
|Principal Investigator:||Mahmoud B Malas, M.D., MHS, FACS|
Umair Qazi, M.D., MPH
|Study Long Title:|
Asymptomatic Carotid Trial
|Study Short Title:||ACT-1|
|JHU IRB Number:|
|Funding Source:||Abbott Vascular|
|Important Inclusion Criteria:|
Subject must be asymptomatic, defined as no stroke or TIA (hemispheric or ocular) within the 180 days prior to the procedure. Subjects who have experienced these neurological symptoms prior to the 180 day pre-procedure window will be eligible for enrollment. An independent study neurologist or independent study neurosurgeon must confirm the subject’s neurological status
Carotid stenosis ≥ 70% and ≤ 99% by carotid ultrasound or ≥ 70% and ≤ 99% stenosis (visual estimate) by angiography, without significant (> 60% by ultrasound or angiography) ICA/CCA contralateral stenosis.
|Important 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 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 known cardiac sources of emboli, including paroxysmal or sustained atrial fibrillation (treated or untreated)
Subject has ha MI within the previous 30 days.
|Clinical Trial Site:||Johns Hopkins Bayview Medical Center|
4940 Eastern Ave
Baltimore MD 21224
|Anticipated End Date:||2014|
|Compensation for Participating:||None|