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GORE Flow Reversal System and GORE Embolic Filter Extension Study

The Gore FREEDOM Study: GORE Flow Reversal System and GORE Embolic Filter Extension Study for the Ongoing Collection of Patient Outcomes

NCT01343667•W.L.Gore & Associates

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (39)

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

Key Dates

Start Date

April 1, 2011

Primary Completion Date

November 1, 2013

Completion Date

January 1, 2014

Last Updated

February 19, 2016

Enrollment

1,397

ACTUAL participants

Conditions

Carotid StenosisConstriction, PathologicCarotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPathological Conditions, Anatomical

Interventions

Gore Flow Reversal System

DEVICE

Gore Embolic Filter

DEVICE

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

NCT07322913

Carotid Artery DiseasesAortic Diseases+1 more

View study

RECRUITINGNA

Remote Ischemic Conditioning Plus Stenting for Symptomatic Carotid Artery Stenosis

NCT07412249

Carotid Stenosis

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

GORE Flow Reversal System and GORE Embolic Filter Extension Study

Inclusion Criteria

Exclusion Criteria

Intervascular Post-Market Clinical Follow-Up (PMCF) Registry

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Comprehensive Assessment of Atherosclerotic Ischemic Stroke Risk and Development of a Prediction Model