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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Trial Summary
Trial Overview
Inclusion Criteria

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
Spirit Physician Services / Capital Cardiovascular Assoc
Camp Hill, Pennsylvania 17011
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Camp Hill, PA
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Emory University
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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Atlanta, GA
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Indiana University
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 Medical Cetner
Appleton, Wisconsin 54911
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Appleton, WI
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Johns Hopkins Hospital
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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Baltimore, MD
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Heritage Valley Health Network
Beaver, Pennsylvania 15009
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Beaver, PA
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Beth Israel Decaoness Medical Center
Boston, Massachusetts 02215
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Boston, MA
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Mercy Hospital
Buffalo, New York 14220
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Buffalo, NY
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Cooper University Hospital
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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Camden, NJ
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Medical University of South Carolina
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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Cleveland Clinic Foundation
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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from
Cleveland, OH
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Riverside Methodist Hospital
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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Columbus, OH
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Harper Hospital
Detroit, Michigan 48201
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Detroit, MI
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St John's Medical Center
Detroit, Michigan 48236
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Detroit, MI
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W.L. Gore and Associates, Inc
Flagstaff, Arizona 86001
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Flagstaff, AZ
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Kaiser Foundation Hospitals
Honolulu, Hawaii 96819
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Honolulu, HI
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St. Luke's Episcopal
Houston, Texas 77030
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Houston, TX
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First Coast Cardiovascular Institute
Jacksonville, Florida 32216
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Jacksonville, FL
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Dartmouth Hitchcock Medical Center
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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Lebanon, NH
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University of Wisconsin
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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Madison, WI
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Southwest General Health Center
Middleburg Heights, Ohio 44130
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Middleburg Heights, OH
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St. Luke's Medical Center
Milwaukee, Wisconsin 53215
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Milwaukee, WI
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Heart Care Research Foundation
Mokena, Illinois 60448
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Mokena, IL
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Ochsner Clinic
New Orleans, Louisiana 70121
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New Orleans, LA
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Mt Sinai Hospital
New York, New York 10029
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New York, NY
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Hoag Memorial Hospital
Newport Beach, California 92663
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Newport Beach, CA
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Drexel University
3301 Lancaster Avenue
Philadelphia, Pennsylvania 19102
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Philadelphia, PA
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St. Joseph Mercy Hospital
Pontiac, Michigan 48341
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Pontiac, MI
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Wake Heart Research
Raleigh, North Carolina 27610
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Raleigh, NC
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Rapid City Regional Hospital
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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Rapid City, SD
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Rockford Cardiovascular Associates
Rockford, Illinois
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Rockford, IL
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St. Francis Hospital
Roslyn, New York 11576
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Roslyn, NY
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Covenant Medical Center
Saginaw, Michigan 48602
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Saginaw, MI
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University of California at San Francisco
San Francisco, California 94143
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San Francisco, CA
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N. Central Heart Hospital
Sioux Falls, South Dakota 57108
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Sioux Falls, SD
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St Anthony's Medical Center
St Louis, Missouri 63128
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St Louis, MO
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St Joesph's Medical Center
St Louis, Missouri 64114
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St Louis, MO
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Forsyth Memorial Hospital, Inc.
Winston Salem, North Carolina 27103
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Winston Salem, NC
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York Hospital
York, Pennsylvania 17315
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York, PA
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