Carotid Artery Stenosis Clinical Trial
Official title:
A Randomized Trial of Carotid Artery Stenting With and Without Cerebral Protection
The primary objective of this study is to evaluate carotid artery stenting (CAS) with and without cerebral protection (CP) to determine if CP improves safety and effectiveness of CAS.
This study is a single center, prospective, randomized trial evaluating the safety and
effectiveness of CAS with and without CP. The study population will be comprised of subjects
with atherosclerotic, post endarterectomy restenotic or other obstructive lesions in native
carotid arteries. Other carotid artery pathology not amenable to surgical repair (for
example carotid artery dissection) will also be considered. Subjects at high risk for
complications from standard CEA will be the target population for this study. High risk
status will be confirmed by two physicians, one of whom is a vascular surgeon. Both
symptomatic and asymptomatic subjects will be enrolled. This will ensure that the proportion
of symptomatic subjects is the same in the two arms of the study. "Symptomatic" is defined
in the exclusion criteria. The expected duration of this clinical trial is 3 years.
In this study there are there are two arms that a subject may be randomized to:
Group1: CAS with the use of the RX ACCUNET Group 2: CAS without the use of the RX ACCUNET
This study has been designed to test whether the addition of CP enhances the safety and
effectiveness of CAS.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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