GORE Flow Reversal System and GORE Embolic Filter Extension Study



Status:Completed
Conditions:Peripheral Vascular Disease, Cardiology, Cardiology, Cardiology, Neurology, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2011
End Date:January 2014

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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.

Inclusion Criteria:

- Patient, or patient's legal representative, is able and willing to provide informed
consent.

- Patient must be at least 18 years of age or older.

- Patient will be selected and treated according to the GORE Flow Reversal System
Instructions for Use (IFU) or the GORE Embolic Filter IFU.

Exclusion Criteria:

- Patient is contraindicated for the embolic protection device arm they are selected by
the investigator to receive: Either Per the GORE Flow Reversal System IFU if the GORE
Flow Reversal System is selected OR Per the GORE Embolic Filter IFU if the GORE
Embolic Filter is selected

If the patient is contraindicated for both arms (devices) they may not be enrolled.
We found this trial at
39
sites
Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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Appleton, Wisconsin 54911
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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Beaver, Pennsylvania 15009
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Boston, Massachusetts 02215
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Buffalo, New York 14220
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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Camp Hill, PA
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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Detroit, Michigan 48201
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Detroit, Michigan 48236
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Flagstaff, Arizona 86001
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Honolulu, Hawaii 96819
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Houston, Texas 77030
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Jacksonville, Florida 32216
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Middleburg Heights, Ohio 44130
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Milwaukee, Wisconsin 53215
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Mokena, Illinois 60448
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New Orleans, Louisiana 70121
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New York, New York 10029
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Newport Beach, California 92663
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3301 Lancaster Avenue
Philadelphia, Pennsylvania 19102
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Pontiac, Michigan 48341
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Raleigh, North Carolina 27610
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353 Fairmont Blvd
Rapid City, South Dakota 57701
(605) 719-1000
Rapid City Regional Hospital Regional Health is an integrated health care system of more than...
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Roslyn, New York 11576
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Saginaw, Michigan 48602
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San Francisco, California 94143
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Sioux Falls, South Dakota 57108
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St Louis, Missouri 63128
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St Louis, Missouri 64114
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Winston Salem, North Carolina 27103
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York, Pennsylvania 17315
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