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
2 other identifiers
interventional
293
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2008
Longer than P75 for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2008
CompletedFirst Posted
Study publicly available on registry
August 19, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
October 21, 2014
CompletedOctober 21, 2014
October 1, 2014
2.7 years
August 15, 2008
February 6, 2014
October 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (12)
Assisted Primary Patency at 6 Months
6 months
Assisted Primary Patency at 12 Months
12 months
Assisted Primary Patency at 24 Months
24 months
Access Secondary Patency at 6 Months
6 months
Access Secondary Patency [12 Months] Units Percentage of Subjects
12 months
- +7 more secondary outcomes
Study Arms (2)
VIABAHN Treatment Group
EXPERIMENTALUse 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
PTA Treatment Group
ACTIVE COMPARATORPercutaneous 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
Interventions
Deployment of investigational stent graft at the venous anastomosis
Percutaneous Transluminal Angioplasty at the venous anastomosis
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Unknown Facility
Birmingham, Alabama, 35249, United States
Unknown Facility
Fresno, California, 93710, United States
Unknown Facility
Inglewood, California, 90301, United States
Unknown Facility
Oceanside, California, 92056, United States
Unknown Facility
Riverside, California, 92501, United States
Unknown Facility
San Diego, California, 92115, United States
Unknown Facility
San Diego, California, 92120, United States
Unknown Facility
San Francisco, California, 94143, United States
Unknown Facility
New Haven, Connecticut, 06520, United States
Unknown Facility
Jacksonville, Florida, 32209, United States
Unknown Facility
Albany, Georgia, 31707-1908, United States
Unknown Facility
Chicago, Illinois, 60612-3833, United States
Unknown Facility
Des Moines, Iowa, 50309, United States
Unknown Facility
Louisville, Kentucky, 40202, United States
Unknown Facility
Baltimore, Maryland, 21239, United States
Unknown Facility
New Brighton, Minnesota, 55112, United States
Unknown Facility
Saint Paul, Minnesota, 55101, United States
Unknown Facility
Cincinnati, Ohio, 45212, United States
Unknown Facility
Cincinnati, Ohio, 45267-0585, United States
Unknown Facility
Dayton, Ohio, 45406, United States
Unknown Facility
Portland, Oregon, 97210, United States
Unknown Facility
Philadelphia, Pennsylvania, 19104, United States
Unknown Facility
Charleston, South Carolina, 29421, United States
Unknown Facility
Greenville, South Carolina, 29615, United States
Unknown Facility
Beaumont, Texas, 77701, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Norfolk, Virginia, 23507, United States
Unknown Facility
Winchester, Virginia, 22601, United States
Unknown Facility
Bellevue, Washington, 98004, United States
Unknown Facility
Spokane, Washington, 99204, United States
Unknown Facility
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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.
PMID: 30717951DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Project Manager
- Organization
- W.L. Gore and Associates, Inc.
Study Officials
- STUDY DIRECTOR
Tom Vesely, MD
Vascular Access Center; Frontenac, MO
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2008
First Posted
August 19, 2008
Study Start
September 1, 2008
Primary Completion
May 1, 2011
Study Completion
June 1, 2013
Last Updated
October 21, 2014
Results First Posted
October 21, 2014
Record last verified: 2014-10