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

January 22, 2016 updated by: W.L.Gore & Associates

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

1397

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: GFRS EPD
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:
  • FRS
  • Neuro Protection System
  • GORE Neuro Protection System
  • Parodi
  • NPS
  • PAES
  • proximal protection
OTHER: GEF EPD
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Onset from start of index procedure to 30-day follow-up assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

W.L.Gore & Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

April 25, 2011

First Submitted That Met QC Criteria

April 27, 2011

First Posted (ESTIMATE)

April 28, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 19, 2016

Last Update Submitted That Met QC Criteria

January 22, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FRS 09-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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