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

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.

Study Overview

• Status: Completed
• Conditions: Renal Failure; Hemodialysis
• Intervention / Treatment: Device: GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface; Procedure: Percutaneous Transluminal Angioplasty

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
• Enrollment (Actual): 293
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
  • California
    • Fresno, California, United States, 93710
    • Inglewood, California, United States, 90301
    • Oceanside, California, United States, 92056
    • Riverside, California, United States, 92501
    • San Diego, California, United States, 92120
    • San Diego, California, United States, 92115
    • San Francisco, California, United States, 94143
  • Connecticut
    • New Haven, Connecticut, United States, 06520
  • Florida
    • Jacksonville, Florida, United States, 32209
  • Georgia
    • Albany, Georgia, United States, 31707-1908
  • Illinois
    • Chicago, Illinois, United States, 60612-3833
  • Iowa
    • Des Moines, Iowa, United States, 50309
  • Kentucky
    • Louisville, Kentucky, United States, 40202
  • Maryland
    • Baltimore, Maryland, United States, 21239
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
    • St. Paul, Minnesota, United States, 55101
  • Ohio
    • Cincinnati, Ohio, United States, 45212
    • Cincinnati, Ohio, United States, 45267-0585
    • Dayton, Ohio, United States, 45406
  • Oregon
    • Portland, Oregon, United States, 97210
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
  • South Carolina
    • Charleston, South Carolina, United States, 29421
    • Greenville, South Carolina, United States, 29615
  • Texas
    • Beaumont, Texas, United States, 77701
    • Houston, Texas, United States, 77030
  • Virginia
    • Norfolk, Virginia, United States, 23507
    • Winchester, Virginia, United States, 22601
  • Washington
    • Bellevue, Washington, United States, 98004
    • Spokane, Washington, United States, 99204
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Primary Patency at 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.	6 months
Target Lesion Primary Patency at 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.	12 Months
Target Lesion Primary Patency at 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.	24 Months
Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure	The primary safety endpoint is freedom from major device, procedure and treatment site-related adverse events through 30 days.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assisted Primary Patency at 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.	6 months
Assisted Primary Patency at 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.	12 months
Assisted Primary Patency at 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.	24 months
Access Secondary Patency at 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.	6 months
Access Secondary Patency [12 Months] Units Percentage of Subjects	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.	12 months
Access Secondary Patency [24 Months] Units Percentage of Subjects	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.	24 months
Circuit Primary Patency	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.	6 months
Circuit Primary Patency [12 Months] Units Percentage of Subjects	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.	12months
Circuit Primary Patency [24 Months] Units Percentage of Subjects	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.	24 months
Clinical Success	The resumption of normal dialysis for at least one session following study treatment (Index Procedure).	Following Index Procedure
Anatomic Success	Less than 30 percent residual stenosis following study treatment (Index Procedure).	Index Procedure
Procedural Success	Participants were considered to have Procedural Success if they achieved both anatomic success and clinical success.	Following Index Procedure

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Study Director: Tom Vesely, MD, Vascular Access Center; Frontenac, MO

Publications and helpful links

General Publications

• Mohr BA, Sheen AL, Roy-Chaudhury P, Schultz SR, Aruny JE; REVISE Investigators. Clinical and Economic Benefits of Stent Grafts in Dysfunctional and Thrombosed Hemodialysis Access Graft Circuits in the REVISE Randomized Trial. J Vasc Interv Radiol. 2019 Feb;30(2):203-211.e4. doi: 10.1016/j.jvir.2018.12.006.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (ACTUAL): May 1, 2011
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: August 15, 2008
• First Submitted That Met QC Criteria: August 18, 2008
• First Posted (ESTIMATE): August 19, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 21, 2014
• Last Update Submitted That Met QC Criteria: October 14, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Hemodialysis; Stent Graft; Venous Anastomosis; Arteriovenous Grafts
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: AVR 06-01; G070069 (OTHER: FDA (IDE))