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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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

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 
Overall Participants Analyzed 
[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 ]
  Show Outcome Measure 1


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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
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