Back to resultsGORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis (REVISE)
Primary Purpose
Renal Failure, Hemodialysis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
Percutaneous Transluminal Angioplasty
Sponsored by
About this trial
This is an interventional treatment trial for Renal Failure focused on measuring Hemodialysis, Stent Graft, Venous Anastomosis, Arteriovenous Grafts
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
VIABAHN Treatment Group
PTA Treatment Group
Arm Description
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
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
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
Clinical Success
The resumption of normal dialysis for at least one session following study treatment (Index Procedure).
Anatomic Success
Less than 30 percent residual stenosis following study treatment (Index Procedure).
Procedural Success
Participants were considered to have Procedural Success if they achieved both anatomic success and clinical success.
Full Information
NCT ID
NCT00737672
First Posted
August 15, 2008
Last Updated
October 14, 2014
Sponsor
W.L.Gore & Associates
1. Study Identification
Unique Protocol Identification Number
NCT00737672
Brief Title
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
Acronym
REVISE
Official Title
GORE VIABAHN® Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise Arteriovenous Grafts at the Venous Anastomosis in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
W.L.Gore & Associates
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure, Hemodialysis
Keywords
Hemodialysis, Stent Graft, Venous Anastomosis, Arteriovenous Grafts
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
293 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VIABAHN Treatment Group
Arm Type
Experimental
Arm Description
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
Arm Title
PTA Treatment Group
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
Intervention Description
Deployment of investigational stent graft at the venous anastomosis
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Transluminal Angioplasty
Intervention Description
Percutaneous Transluminal Angioplasty at the venous anastomosis
Primary Outcome Measure Information:
Title
Target Lesion Primary Patency at 6 Months
Description
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.
Time Frame
6 months
Title
Target Lesion Primary Patency at 12 Months
Description
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.
Time Frame
12 Months
Title
Target Lesion Primary Patency at 24 Months
Description
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.
Time Frame
24 Months
Title
Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure
Description
The primary safety endpoint is freedom from major device, procedure and treatment site-related adverse events through 30 days.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Assisted Primary Patency at 6 Months
Description
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.
Time Frame
6 months
Title
Assisted Primary Patency at 12 Months
Description
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.
Time Frame
12 months
Title
Assisted Primary Patency at 24 Months
Description
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.
Time Frame
24 months
Title
Access Secondary Patency at 6 Months
Description
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.
Time Frame
6 months
Title
Access Secondary Patency [12 Months] Units Percentage of Subjects
Description
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.
Time Frame
12 months
Title
Access Secondary Patency [24 Months] Units Percentage of Subjects
Description
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.
Time Frame
24 months
Title
Circuit Primary Patency
Description
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.
Time Frame
6 months
Title
Circuit Primary Patency [12 Months] Units Percentage of Subjects
Description
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.
Time Frame
12months
Title
Circuit Primary Patency [24 Months] Units Percentage of Subjects
Description
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.
Time Frame
24 months
Title
Clinical Success
Description
The resumption of normal dialysis for at least one session following study treatment (Index Procedure).
Time Frame
Following Index Procedure
Title
Anatomic Success
Description
Less than 30 percent residual stenosis following study treatment (Index Procedure).
Time Frame
Index Procedure
Title
Procedural Success
Description
Participants were considered to have Procedural Success if they achieved both anatomic success and clinical success.
Time Frame
Following Index Procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Vesely, MD
Organizational Affiliation
Vascular Access Center; Frontenac, MO
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92115
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
City
Albany
State/Province
Georgia
ZIP/Postal Code
31707-1908
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-3833
Country
United States
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21239
Country
United States
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0585
Country
United States
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29421
Country
United States
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30717951
Citation
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.
Results Reference
derived
Learn more about this trial
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
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