GORE Flow Reversal System and GORE Embolic Filter Extension Study
NCT ID: NCT01343667
Last Updated: 2016-02-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1397 participants
INTERVENTIONAL
2011-04-30
2014-01-31
Brief Summary
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Detailed Description
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This study is not designed to compare study endpoints between the two treatment arms.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GFRS EPD
Carotid artery stenting with Gore Flow Reversal System embolic protection device
Gore Flow Reversal System
Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting
GEF EPD
Carotid artery stenting with Gore Embolic Filter embolic protection device
Gore Embolic Filter
Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting
Interventions
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Gore Flow Reversal System
Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting
Gore Embolic Filter
Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
If the patient is contraindicated for both arms (devices) they may not be enrolled.
18 Years
ALL
No
Sponsors
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W.L.Gore & Associates
INDUSTRY
Responsible Party
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Locations
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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
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
Johns Hopkins Hospital
Baltimore, Maryland, United States
Beth Israel Decaoness Medical Center
Boston, Massachusetts, United States
Harper Hospital
Detroit, Michigan, United States
St John's Medical Center
Detroit, Michigan, United States
St Joseph Mercy Hospital
Pontiac, Michigan, United States
Covenant Medical Center
Saginaw, Michigan, United States
St Anthony's Medical Center
St Louis, Missouri, United States
St Joesph's Medical Center
St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cooper University Hospital
Camden, New Jersey, United States
Mercy Hospital
Buffalo, New York, United States
Mt Sinai Hospital
New York, New York, United States
St Francis Hospital
Roslyn, New York, United States
Wake Heart Research
Raleigh, North Carolina, United States
Forsyth Memorial Hospital
Winston-Salem, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Southwest General Health Center
Middleburg Heights, Ohio, United States
Heritage Valley Health Network
Beaver, Pennsylvania, United States
Spirit Physician Services / Capital Cardiovascular Assoc
Camp Hill, Pennsylvania, United States
Drexel University
Philadelphia, Pennsylvania, United States
York Hospital
York, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
N. Central Heart Hospital
Sioux Falls, South Dakota, United States
St Luke's Episcopal
Houston, Texas, United States
Appleton Medical Cetner
Appleton, Wisconsin, United States
University of Wisconsin
Madison, Wisconsin, United States
St Lukes Medical Center
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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FRS 09-05
Identifier Type: -
Identifier Source: org_study_id
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