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

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ClinicalTrials.gov Identifier: NCT00737672
Recruitment Status : Completed
First Posted : August 19, 2008
Results First Posted : October 21, 2014
Last Update Posted : October 21, 2014
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates

Brief Summary:
The objective of the study is to establish efficacy and safety of the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the maintenance or re-establishment of vascular access for hemodialysis.

Condition or disease Intervention/treatment Phase
Renal Failure Hemodialysis Device: GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface Procedure: Percutaneous Transluminal Angioplasty Phase 3

Detailed Description:

The primary effectiveness hypothesis is to demonstrate that the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface will extend the period of target lesion primary patency as compared to PTA.

The primary safety hypothesis is to demonstrate that the proportion of subjects remaining free from major device, procedure, and treatment site-related adverse events through 30 days post-procedure in the GORE® VIABAHN® Device group is not inferior to that of the PTA group.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 293 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: GORE VIABAHN® Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise Arteriovenous Grafts at the Venous Anastomosis in Hemodialysis Patients
Study Start Date : September 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty Dialysis

Arm Intervention/treatment
Experimental: 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
Device: GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
Deployment of investigational stent graft at the venous anastomosis

Active Comparator: 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
Procedure: Percutaneous Transluminal Angioplasty
Percutaneous Transluminal Angioplasty at the venous anastomosis




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

    Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.

    Six-month estimate of target lesion primary patency derived from Kaplan-Meier curve.


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

    Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.

    Twelve-month estimate of target lesion primary patency derived from Kaplan-Meier curve.


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

    Kaplan-Meier estimate of the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.

    P-Value calculated from 24-month data cohort after study completion.


  4. Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure [ Time Frame: 30 days ]
    The primary safety endpoint is freedom from major device, procedure and treatment site-related adverse events through 30 days.


Secondary Outcome Measures :
  1. Assisted Primary Patency at 6 Months [ Time Frame: 6 months ]

    Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.

    Six-month estimate of assisted primary patency derived from Kaplan-Meier curve.


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

    Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.

    Twelve-month estimate of assisted primary patency derived from Kaplan-Meier curve.


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

    Kaplan-Meier estimate of the time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.

    Twenty-four-month estimate of assisted primary patency derived from Kaplan-Meier curve.


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

    Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.

    Six-month estimate of secondary access patency derived from Kaplan-Meier curve.


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

    Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.

    Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve.


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

    Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.

    24-month estimate of secondary access secondary patency derived from Kaplan-Meier curve.


  7. Circuit Primary Patency [ Time Frame: 6 months ]

    Kaplan-Meier estimate of the time interval from initial study treatment to the next access thrombosis or intervention performed within the vascular access circuit.

    P-Value calculated from 24-month data cohort. Six-month estimate of circuit primary patency derived from Kaplan-Meier curve.


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

    Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.

    Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve.


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

    Kaplan-Meier estimate of the time interval from initial study treatment to abandonment of the vascular access circuit.

    Twelve-month estimate of secondary access secondary patency derived from Kaplan-Meier curve.


  10. Clinical Success [ Time Frame: Following Index Procedure ]
    The resumption of normal dialysis for at least one session following study treatment (Index Procedure).

  11. Anatomic Success [ Time Frame: Index Procedure ]
    Less than 30 percent residual stenosis following study treatment (Index Procedure).

  12. Procedural Success [ Time Frame: Following Index Procedure ]
    Participants were considered to have Procedural Success if they achieved both anatomic success and clinical success.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hemodialysis patient with a dysfunctional or thrombosed forearm or upper arm prosthetic vascular access graft.
  • The target lesion starts less than or equal to 30 mm from the venous anastomosis.
  • The target lesion has > 50% stenosis as measured per protocol.
  • The patient has a maximum of one secondary stenosis.

Exclusion Criteria:

  • The age of the hemodialysis access graft is less than or equal to 30 days old from the date of the study procedure.
  • The patient has undergone an intervention (surgical or percutaneous) of the vascular access circuit less than or equal to 30 days from the date of the study procedure.
  • The secondary lesion is an occlusion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737672


  Show 31 Study Locations
Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Study Director: Tom Vesely, MD Vascular Access Center; Frontenac, MO

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) )
First Posted: August 19, 2008    Key Record Dates
Results First Posted: October 21, 2014
Last Update Posted: October 21, 2014
Last Verified: October 2014

Keywords provided by W.L.Gore & Associates:
Hemodialysis
Stent Graft
Venous Anastomosis
Arteriovenous Grafts

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases