GORE Flow Reversal System and GORE Embolic Filter Extension Study
FREEDOM
The Gore FREEDOM Study: GORE Flow Reversal System and GORE Embolic Filter Extension Study for the Ongoing Collection of Patient Outcomes
1 other identifier
interventional
1,397
1 country
39
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2011
Typical duration for not_applicable
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 25, 2011
CompletedFirst Posted
Study publicly available on registry
April 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
February 19, 2016
CompletedFebruary 19, 2016
January 1, 2016
2.6 years
April 25, 2011
December 15, 2015
January 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major Adverse Events (MAE)
Major Adverse Events include death, stroke and myocardial infarction
Onset from start of index procedure to 30-day follow-up assessment
Study Arms (2)
GFRS EPD
OTHERCarotid artery stenting with Gore Flow Reversal System embolic protection device
GEF EPD
OTHERCarotid artery stenting with Gore Embolic Filter embolic protection device
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
W.L. Gore and Associates, Inc
Flagstaff, Arizona, 86001, United States
Hoag Memorial Hospital
Newport Beach, California, 92663, United States
University of California San Francisco
San Francisco, California, 94143, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, 32216, United States
Emory University
Atlanta, Georgia, 30322, United States
Kaiser FOundation Hospitals
Honolulu, Hawaii, 96819, United States
Heart Care Research Foundation
Mokena, Illinois, 60488, United States
Rockford Cardiovascular Associates
Rockford, Illinois, 61107, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Ochsner Clinic
New Orleans, Louisiana, 70121, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21205, United States
Beth Israel Decaoness Medical Center
Boston, Massachusetts, 02215, United States
Harper Hospital
Detroit, Michigan, 48201, United States
St John's Medical Center
Detroit, Michigan, 48236, United States
St Joseph Mercy Hospital
Pontiac, Michigan, 48341, United States
Covenant Medical Center
Saginaw, Michigan, 48602, United States
St Anthony's Medical Center
St Louis, Missouri, 63128, United States
St Joesph's Medical Center
St Louis, Missouri, 64114, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Mercy Hospital
Buffalo, New York, 14220, United States
Mt Sinai Hospital
New York, New York, 10029, United States
St Francis Hospital
Roslyn, New York, 11576, United States
Wake Heart Research
Raleigh, North Carolina, 26610, United States
Forsyth Memorial Hospital
Winston-Salem, North Carolina, 27103, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Southwest General Health Center
Middleburg Heights, Ohio, 44130, United States
Heritage Valley Health Network
Beaver, Pennsylvania, 15009, United States
Spirit Physician Services / Capital Cardiovascular Assoc
Camp Hill, Pennsylvania, 17011, United States
Drexel University
Philadelphia, Pennsylvania, 19102, United States
York Hospital
York, Pennsylvania, 17405, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
N. Central Heart Hospital
Sioux Falls, South Dakota, 57108, United States
St Luke's Episcopal
Houston, Texas, 77030, United States
Appleton Medical Cetner
Appleton, Wisconsin, 54911, United States
University of Wisconsin
Madison, Wisconsin, 53792, United States
St Lukes Medical Center
Milwaukee, Wisconsin, 53215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bryan Randall, Clinical Biostatistician
- Organization
- W. L. Gore & Associates
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2011
First Posted
April 28, 2011
Study Start
April 1, 2011
Primary Completion
November 1, 2013
Study Completion
January 1, 2014
Last Updated
February 19, 2016
Results First Posted
February 19, 2016
Record last verified: 2016-01