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

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ClinicalTrials.gov Identifier: NCT01343667
Recruitment Status : Completed
First Posted : April 28, 2011
Results First Posted : February 19, 2016
Last Update Posted : February 19, 2016
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions 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
Interventions Device: Gore Flow Reversal System
Device: Gore Embolic Filter
Enrollment 1397
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GFRS EPD GEF EPD
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Carotid artery stenting with Gore Flow Reversal System

Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting

Carotid artery stenting with Gore Embolic Filter

Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting

Period Title: Overall Study
Started 425 972
Completed 413 916
Not Completed 12 56
Arm/Group Title GFRS EPD GEF EPD Total
Hide Arm/Group Description

Carotid artery stenting with Gore Flow Reversal System

Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting

Carotid artery stenting with Gore Embolic Filter

Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting

Total of all reporting groups
Overall Number of Baseline Participants 425 972 1397
Hide Baseline Analysis Population Description
All Enrolled Subjects
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 425 participants 972 participants 1397 participants
72.7  (8.7) 73.0  (9.4) 72.9  (9.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 425 participants 972 participants 1397 participants
Female
139
  32.7%
587
  60.4%
726
  52.0%
Male
286
  67.3%
385
  39.6%
671
  48.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 425 participants 972 participants 1397 participants
Hispanic or Latino
11
   2.6%
16
   1.6%
27
   1.9%
Not Hispanic or Latino
414
  97.4%
955
  98.3%
1369
  98.0%
Unknown or Not Reported
0
   0.0%
1
   0.1%
1
   0.1%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 425 participants 972 participants 1397 participants
American Indian or Alaska Native 8 9 17
Asian 7 8 15
Black or African American 26 56 82
Native Hawaiian or Other Pacific Islander 2 1 3
White or Caucasian 381 901 1282
Not Reported 2 1 3
[1]
Measure Description: This measure is structured as a "check all that apply" field on the Case Report Form. Thus, the race categories are not mutually exclusive, except that "Not Reported" is mutually exclusive with the others. Because of this, the sum of the individual category counts is greater than the overall number of participants.
1.Primary Outcome
Title Major Adverse Events (MAE)
Hide Description Major Adverse Events include death, stroke and myocardial infarction
Time Frame Onset from start of index procedure to 30-day follow-up assessment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Enrolled subjects with successful procedure and sufficient follow-up
Arm/Group Title GFRS EPD GEF EPD
Hide Arm/Group Description:

Carotid artery stenting with Gore Flow Reversal System embolic protection device

Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting

Carotid artery stenting with Gore Embolic Filter embolic protection device

Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting

Overall Number of Participants Analyzed 386 864
Measure Type: Number
Unit of Measure: participants
18 36
Time Frame 30-day visit window
Adverse Event Reporting Description The Major Adverse Event components are reported as individual Serious Adverse Events. No other adverse events were collected in this study, so the number of subjects affected by Other (Not Including Serious) Adverse Events is zero (0).
 
Arm/Group Title GFRS EPD GEF EPD
Hide Arm/Group Description

Carotid artery stenting with Gore Flow Reversal System

Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting

Carotid artery stenting with Gore Embolic Filter

Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting

All-Cause Mortality
GFRS EPD GEF EPD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
GFRS EPD GEF EPD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/425 (4.24%)      36/972 (3.70%)    
Cardiac disorders     
All Cause Death *  2/425 (0.47%)  2 10/972 (1.03%)  10
Myocardial Infarction *  6/425 (1.41%)  6 3/972 (0.31%)  3
Nervous system disorders     
Stroke *  14/425 (3.29%)  14 31/972 (3.19%)  31
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.1%
GFRS EPD GEF EPD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/425 (0.00%)      0/972 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Bryan Randall, Clinical Biostatistician
Organization: W. L. Gore & Associates
Phone: 928-864-4832
Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01343667     History of Changes
Other Study ID Numbers: FRS 09-05
First Submitted: April 25, 2011
First Posted: April 28, 2011
Results First Submitted: December 15, 2015
Results First Posted: February 19, 2016
Last Update Posted: February 19, 2016