Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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 Intervention Phase
Renal Failure
Hemodialysis
Device: GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
Procedure: Percutaneous Transluminal Angioplasty
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 293
Study Start Date: September 2008
Study Completion Date: June 2013
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: 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
Procedure: Percutaneous Transluminal Angioplasty
Percutaneous Transluminal Angioplasty at the venous anastomosis

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00737672

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

No publications provided

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT00737672     History of Changes
Other Study ID Numbers: AVR 06-01, G070069
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

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

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 24, 2014