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GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis (REVISE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT00737672
First received: August 15, 2008
Last updated: October 14, 2014
Last verified: October 2014
Results First Received: February 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Renal Failure
Hemodialysis
Interventions: Device: GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
Procedure: Percutaneous Transluminal Angioplasty

  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
VIABAHN Treatment Group

Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm

GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis

PTA Treatment Group

Percutaneous Transluminal Angioplasty (PTA)in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm

Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis


Participant Flow:   Overall Study
    VIABAHN Treatment Group   PTA Treatment Group
STARTED   145   148 
Exclusions Due to Protocol Deviations   14   10 
Per Protocol Population   131   138 
COMPLETED   65   65 
NOT COMPLETED   80   83 
Graft Abandonment                48                56 
Death                23                22 
Withdrawal by Subject                1                2 
Lost to Follow-up                1                0 
Miscellaneous                7                1 
Physician Decision                0                2 



  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.
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Reporting Groups
  Description
VIABAHN Treatment Group

Use of GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Comparator Arm.

GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface: Deployment of investigational stent graft at the venous anastomosis.

PTA Treatment Group

Percutaneous Transluminal Angioplasty (PTA) in arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis as compared to Experimental Arm.

Percutaneous Transluminal Angioplasty: Percutaneous Transluminal Angioplasty at the venous anastomosis.

Total Total of all reporting groups

Baseline Measures
   VIABAHN Treatment Group   PTA Treatment Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 145   148   293 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.2  (12.9)   61.3  (15.0)   61.7  (14.0) 
Gender 
[Units: Participants]
     
Female   76   75   151 
Male   69   73   142 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   16   30   46 
Not Hispanic or Latino   126   114   240 
Unknown or Not Reported   3   4   7 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   1   1 
Asian   9   7   16 
Native Hawaiian or Other Pacific Islander   1   0   1 
Black or African American   74   80   154 
White   61   56   117 
More than one race   0   0   0 
Unknown or Not Reported   0   4   4 
Region of Enrollment 
[Units: Participants]
     
United States   145   148   293 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 29.7  (9.1)   29.5  (8.6)   29.6  (8.8) 
History of Diabetes 
[Units: Participants]
     
History of Diabetes = YES   94   98   192 
History of Diabetes = NO   51   50   101 
History of Hypertension 
[Units: Participants]
     
History of Hypertension = YES   143   144   287 
History of Hypertension = NO   2   4   6 
Age of Vascular Access Graft 
[Units: Years]
Mean (Standard Deviation)
 1.93  (1.92)   2.28  (2.64)   2.11  (2.31) 
Total Number of Prior Interventions at the Target Lesions 
[Units: Number of Prior Interventions]
Mean (Standard Deviation)
 1.85  (2.20)   1.81  (2.34)   1.83  (2.27) 
Total Number of Prior Interventions to the Current Prosthetic Graft or Circuit 
[Units: Number of Prior Interventions]
Mean (Standard Deviation)
 2.28  (2.75)   2.26  (2.90)   2.27  (2.82) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Target Lesion Primary Patency at 6 Months   [ Time Frame: 6 months ]

2.  Primary:   Target Lesion Primary Patency at 12 Months   [ Time Frame: 12 Months ]

3.  Primary:   Target Lesion Primary Patency at 24 Months   [ Time Frame: 24 Months ]

4.  Primary:   Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure   [ Time Frame: 30 days ]

5.  Secondary:   Assisted Primary Patency at 6 Months   [ Time Frame: 6 months ]

6.  Secondary:   Assisted Primary Patency at 12 Months   [ Time Frame: 12 months ]

7.  Secondary:   Assisted Primary Patency at 24 Months   [ Time Frame: 24 months ]

8.  Secondary:   Access Secondary Patency at 6 Months   [ Time Frame: 6 months ]

9.  Secondary:   Access Secondary Patency [12 Months] Units Percentage of Subjects   [ Time Frame: 12 months ]

10.  Secondary:   Access Secondary Patency [24 Months] Units Percentage of Subjects   [ Time Frame: 24 months ]

11.  Secondary:   Circuit Primary Patency   [ Time Frame: 6 months ]

12.  Secondary:   Circuit Primary Patency [12 Months] Units Percentage of Subjects   [ Time Frame: 12months ]

13.  Secondary:   Circuit Primary Patency [24 Months] Units Percentage of Subjects   [ Time Frame: 24 months ]

14.  Secondary:   Clinical Success   [ Time Frame: Following Index Procedure ]

15.  Secondary:   Anatomic Success   [ Time Frame: Index Procedure ]

16.  Secondary:   Procedural Success   [ Time Frame: Following Index Procedure ]


  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: Clinical Project Manager
Organization: W.L. Gore and Associates, Inc.
phone: 928-864-3771
e-mail: cavery@wlgore.com



Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00737672     History of Changes
Other Study ID Numbers: AVR 06-01
G070069 ( Other Identifier: FDA (IDE) )
Study First Received: August 15, 2008
Results First Received: February 6, 2014
Last Updated: October 14, 2014
Health Authority: United States: Food and Drug Administration