GORE Carotid Stent Clinical Study for the treatment of carotid artery stenosis in patients at increased risk for adverse events from carotid endarterectomy
The purpose of this study is to evaluate the safety and effectiveness of the Gore Carotid Stent for treatment of carotid artery stenosis in pts. at high risk for carotid endarterectomy which is the surgical procedure for this condition. Patients must be 18 or older, have more than 50% stenosis if symptomatic or more than 80% if asymptomatic, and have co-morbidities that place them at high risk for CEA. Subjects will undergo clinically indicated CAS with the investigational Gore Carotid Stent and will be followed at 30 days, 6 mos. 1,2,and 3 years with office visits that include carotid ultrasounds and brief standardized neuro exams.
- Study Identifier: 818321
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