Stroke Clinical Trial
Official title:
Carotid Endarterectomy Versus Optimal Medical Treatment of Asymptomatic High Grade Carotid Artery Stenosis
The aim of this study is to determine whether optimal medical treatment can postpone carotid endarterectomy.
It is well known that risk of fatal and non-fatal stroke is increased in patients with
significant carotid atherosclerosis. For asymptomatic patients, AHA guidelines recommend
carotid endarterectomy (CEA) for stenosis 60% to 99%, if the risk of perioperative stroke or
death is less than 3%.
Although clinical trial data support CEA in asymptomatic patients with carotid stenosis 60%
to 79%, the AHA guidelines indicate that some physicians delay revascularization until there
is greater than 80% stenosis in asymptomatic patients.
Our study is designed to determine whether optimal medical therapy alone reduces the risk of
death and nonfatal stroke in patients with carotid artery stenosis as compared with CEA
coupled with optimal medical therapy.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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