FREEDOMThe Gore FREEDOM Study: GORE Flow Reversal System and GORE Embolic Filter Extension Study for the Ongoing Collection of Patient Outcomes
Gore Flow Reversal System
+ Gore Embolic Filter
Arterial Occlusive Diseases+9
+ Brain Diseases
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: April 1, 2011
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.1397 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Group II
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 39 locations
W.L. Gore and Associates, Inc
Flagstaff, United StatesOpen W.L. Gore and Associates, Inc in Google MapsHoag Memorial Hospital
Newport Beach, United StatesUniversity of California San Francisco
San Francisco, United StatesFirst Coast Cardiovascular Institute
Jacksonville, United States