GORE Embolic Protection With Reverse Flow

The GORE Flow Reversal System, manufactured by W. L. Gore \& Associates, Inc., was developed as a proximal occlusion device to reverse the flow of blood in the carotid artery. It is designed to achieve embolic protection prior to crossing the lesion in the majority of cases in order to minimize the possibility of an adverse event occurrence. The objective of this study is to assess the safety and effectiveness of the GORE Flow Reversal System when used to provide embolic protection during Carotid Artery Stent (CAS) procedures. Subjects diagnosed with carotid stenosis requiring revascularization and are at high risk for adverse events from CEA are eligible to participate.