GORE Flow Reversal System and GORE Embolic Filter Extension Study (FREEDOM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01343667
Recruitment Status : Completed
First Posted : April 28, 2011
Results First Posted : February 19, 2016
Last Update Posted : February 19, 2016
Information provided by (Responsible Party):
W.L.Gore & Associates

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.

Condition or disease Intervention/treatment Phase
Carotid Stenosis Constriction, Pathologic Carotid Artery Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Pathological Conditions, Anatomical Device: Gore Flow Reversal System Device: Gore Embolic Filter Not Applicable

Detailed Description:

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  (Clinical Trial)
Actual Enrollment : 1397 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Gore FREEDOM Study: GORE Flow Reversal System and GORE Embolic Filter Extension Study for the Ongoing Collection of Patient Outcomes
Study Start Date : April 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : January 2014

Arm Intervention/treatment
Carotid artery stenting with Gore Flow Reversal System embolic protection device
Device: Gore Flow Reversal System
Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting
Other Names:
  • Neuro Protection System
  • GORE Neuro Protection System
  • Parodi
  • NPS
  • FRS
  • PAES
  • proximal protection

Carotid artery stenting with Gore Embolic Filter embolic protection device
Device: Gore Embolic Filter
Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting
Other Names:
  • embolic filter
  • distal protection

Primary Outcome Measures :
  1. Major Adverse Events (MAE) [ Time Frame: Onset from start of index procedure to 30-day follow-up assessment ]
    Major Adverse Events include death, stroke and myocardial infarction

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01343667

  Hide Study Locations
United States, Arizona
W.L. Gore and Associates, Inc
Flagstaff, Arizona, United States, 86001
United States, California
Hoag Memorial Hospital
Newport Beach, California, United States, 92663
University of California San Francisco
San Francisco, California, United States, 94143
United States, Florida
First Coast Cardiovascular Institute
Jacksonville, Florida, United States, 32216
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Hawaii
Kaiser FOundation Hospitals
Honolulu, Hawaii, United States, 96819
United States, Illinois
Heart Care Research Foundation
Mokena, Illinois, United States, 60488
Rockford Cardiovascular Associates
Rockford, Illinois, United States, 61107
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Beth Israel Decaoness Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Harper Hospital
Detroit, Michigan, United States, 48201
St John's Medical Center
Detroit, Michigan, United States, 48236
St Joseph Mercy Hospital
Pontiac, Michigan, United States, 48341
Covenant Medical Center
Saginaw, Michigan, United States, 48602
United States, Missouri
St Anthony's Medical Center
St Louis, Missouri, United States, 63128
St Joesph's Medical Center
St Louis, Missouri, United States, 64114
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
United States, New York
Mercy Hospital
Buffalo, New York, United States, 14220
Mt Sinai Hospital
New York, New York, United States, 10029
St Francis Hospital
Roslyn, New York, United States, 11576
United States, North Carolina
Wake Heart Research
Raleigh, North Carolina, United States, 26610
Forsyth Memorial Hospital
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Southwest General Health Center
Middleburg Heights, Ohio, United States, 44130
United States, Pennsylvania
Heritage Valley Health Network
Beaver, Pennsylvania, United States, 15009
Spirit Physician Services / Capital Cardiovascular Assoc
Camp Hill, Pennsylvania, United States, 17011
Drexel University
Philadelphia, Pennsylvania, United States, 19102
York Hospital
York, Pennsylvania, United States, 17405
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
N. Central Heart Hospital
Sioux Falls, South Dakota, United States, 57108
United States, Texas
St Luke's Episcopal
Houston, Texas, United States, 77030
United States, Wisconsin
Appleton Medical Cetner
Appleton, Wisconsin, United States, 54911
University of Wisconsin
Madison, Wisconsin, United States, 53792
St Lukes Medical Center
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
W.L.Gore & Associates

Responsible Party: W.L.Gore & Associates Identifier: NCT01343667     History of Changes
Other Study ID Numbers: FRS 09-05
First Posted: April 28, 2011    Key Record Dates
Results First Posted: February 19, 2016
Last Update Posted: February 19, 2016
Last Verified: January 2016

Keywords provided by W.L.Gore & Associates:
GORE Neuro Protection System
GORE Flow Reversal System
carotid artery stenosis
embolic protection device
reverse flow
proximal occlusion device
distal embolization
minimizing risks of CAS
embolic filter

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases
Nervous System Diseases
Brain Diseases
Arterial Occlusive Diseases
Carotid Stenosis
Central Nervous System Diseases
Cerebrovascular Disorders
Carotid Artery Diseases
Constriction, Pathologic
Pathological Conditions, Anatomical