Cardiovascular Diseases Clinical Trial
Official title:
The Gore FREEDOM Study: GORE Flow Reversal System and GORE Embolic Filter Extension Study for the Ongoing Collection of Patient Outcomes
The objective of this study is to provide an ongoing evaluation of clinical outcomes associated with the GORE Flow Reversal System and the GORE Embolic Filter when used for embolic protection during carotid artery stenting.
Physicians will have the opportunity to select which embolic protection device, the GORE
Flow Reversal System or the GORE Embolic Filter, to use during the carotid artery stenting
procedure.
This study is not designed to compare study endpoints between the two treatment arms.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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