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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT01343667
First received: April 25, 2011
Last updated: January 22, 2016
Last verified: January 2016
Results First Received: December 15, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
GFRS EPD

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

GEF EPD

Carotid artery stenting with Gore Embolic Filter

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


Participant Flow:   Overall Study
    GFRS EPD     GEF EPD  
STARTED     425     972  
COMPLETED     413     916  
NOT COMPLETED     12     56  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All Enrolled Subjects

Reporting Groups
  Description
GFRS EPD

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

GEF EPD

Carotid artery stenting with Gore Embolic Filter

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

Total Total of all reporting groups

Baseline Measures
    GFRS EPD     GEF EPD     Total  
Number of Participants  
[units: participants]
  425     972     1397  
Age  
[units: years]
Mean (Standard Deviation)
  72.7  (8.7)     73.0  (9.4)     72.9  (9.2)  
Gender  
[units: participants]
     
Female     139     587     726  
Male     286     385     671  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     11     16     27  
Not Hispanic or Latino     414     955     1369  
Unknown or Not Reported     0     1     1  
Race/Ethnicity, Customized [1]
[units: 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] 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.



  Outcome Measures

1.  Primary:   Major Adverse Events (MAE)   [ Time Frame: Onset from start of index procedure to 30-day follow-up assessment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: BRandall@WLGore.com



Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01343667     History of Changes
Other Study ID Numbers: FRS 09-05
Study First Received: April 25, 2011
Results First Received: December 15, 2015
Last Updated: January 22, 2016
Health Authority: United States: Food and Drug Administration