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

August 15, 2008
October 14, 2014
September 2008
May 2011   (final data collection date for primary outcome measure)
  • Target Lesion Primary Patency at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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.

  • Target Lesion Primary Patency at 12 Months [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

    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.

  • Target Lesion Primary Patency at 24 Months [ Time Frame: 24 Months ] [ Designated as safety issue: No ]

    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.

  • Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    The primary safety endpoint is freedom from major device, procedure and treatment site-related adverse events through 30 days.
Target Lesion Primary Patency [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00737672 on ClinicalTrials.gov Archive Site
  • Assisted Primary Patency at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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.

  • Assisted Primary Patency at 12 Months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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.

  • Assisted Primary Patency at 24 Months [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    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.

  • Access Secondary Patency at 6 Months [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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.

  • Access Secondary Patency [12 Months] Units Percentage of Subjects [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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.

  • Access Secondary Patency [24 Months] Units Percentage of Subjects [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    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.

  • Circuit Primary Patency [ Time Frame: 6 months ] [ Designated as safety issue: No ]

    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.

  • Circuit Primary Patency [12 Months] Units Percentage of Subjects [ Time Frame: 12months ] [ Designated as safety issue: No ]

    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.

  • Circuit Primary Patency [24 Months] Units Percentage of Subjects [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    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.

  • Clinical Success [ Time Frame: Following Index Procedure ] [ Designated as safety issue: No ]
    The resumption of normal dialysis for at least one session following study treatment (Index Procedure).
  • Anatomic Success [ Time Frame: Index Procedure ] [ Designated as safety issue: No ]
    Less than 30 percent residual stenosis following study treatment (Index Procedure).
  • Procedural Success [ Time Frame: Following Index Procedure ] [ Designated as safety issue: No ]
    Participants were considered to have Procedural Success if they achieved both anatomic success and clinical success.
  • Assisted Primary Patency [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Access Secondary Patency [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
GORE VIABAHN® Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise Arteriovenous Grafts at the Venous Anastomosis in Hemodialysis Patients

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Renal Failure
  • Hemodialysis
  • Device: GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
    Deployment of investigational stent graft at the venous anastomosis
    Other Name: GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
  • Procedure: Percutaneous Transluminal Angioplasty
    Percutaneous Transluminal Angioplasty at the venous anastomosis
  • 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
    Intervention: Device: GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
  • 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
    Intervention: Procedure: Percutaneous Transluminal Angioplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
293
June 2013
May 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00737672
AVR 06-01, G070069
Yes
W.L.Gore & Associates
W.L.Gore & Associates
Not Provided
Study Director: Tom Vesely, MD Vascular Access Center; Frontenac, MO
W.L.Gore & Associates
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP