GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
NCT ID: NCT00737672
Last Updated: 2014-10-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
293 participants
INTERVENTIONAL
2008-09-30
2013-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
Deployment of investigational stent graft at the venous anastomosis
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
Percutaneous Transluminal Angioplasty
Percutaneous Transluminal Angioplasty at the venous anastomosis
Interventions
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GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
Deployment of investigational stent graft at the venous anastomosis
Percutaneous Transluminal Angioplasty
Percutaneous Transluminal Angioplasty at the venous anastomosis
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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W.L.Gore & Associates
INDUSTRY
Responsible Party
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Principal Investigators
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Tom Vesely, MD
Role: STUDY_DIRECTOR
Vascular Access Center; Frontenac, MO
Locations
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Birmingham, Alabama, United States
Fresno, California, United States
Inglewood, California, United States
Oceanside, California, United States
Riverside, California, United States
San Diego, California, United States
San Diego, California, United States
San Francisco, California, United States
New Haven, Connecticut, United States
Jacksonville, Florida, United States
Albany, Georgia, United States
Chicago, Illinois, United States
Des Moines, Iowa, United States
Louisville, Kentucky, United States
Baltimore, Maryland, United States
New Brighton, Minnesota, United States
Saint Paul, Minnesota, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Greenville, South Carolina, United States
Beaumont, Texas, United States
Houston, Texas, United States
Norfolk, Virginia, United States
Winchester, Virginia, United States
Bellevue, Washington, United States
Spokane, Washington, United States
Milwaukee, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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G070069
Identifier Type: OTHER
Identifier Source: secondary_id
AVR 06-01
Identifier Type: -
Identifier Source: org_study_id
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