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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,397
Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting
Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting
W.L. Gore and Associates, Inc
Flagstaff, Arizona, United States
Hoag Memorial Hospital
Newport Beach, California, United States
University of California San Francisco
San Francisco, California, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Emory University
Atlanta, Georgia, United States
Major Adverse Events (MAE)
Major Adverse Events include death, stroke and myocardial infarction
Time frame: Onset from start of index procedure to 30-day follow-up assessment
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Kaiser FOundation Hospitals
Honolulu, Hawaii, United States
Heart Care Research Foundation
Mokena, Illinois, United States
Rockford Cardiovascular Associates
Rockford, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Ochsner Clinic
New Orleans, Louisiana, United States
...and 29 more locations