Clinical trial NCT00737672: GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
Official title: GORE VIABAHN® Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise Arteriovenous Grafts at the Venous Anastomosis in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Failure
Hemodialysis
Keywords: Hemodialysis
Stent Graft
Venous Anastomosis
Arteriovenous Grafts
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2008-08-19
Enrollment: 293
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Target Lesion Primary Patency at 6 Months
timeFrame: 6 months
measure: Target Lesion Primary Patency at 12 Months
timeFrame: 12 Months
measure: Target Lesion Primary Patency at 24 Months
timeFrame: 24 Months
measure: Freedom From Major Device, Procedure and Treatment Site-related Adverse Adverse Events Through 30 Days Post-procedure
timeFrame: 30 days
Secondary outcomes:
measure: Assisted Primary Patency at 6 Months
timeFrame: 6 months
measure: Assisted Primary Patency at 12 Months
timeFrame: 12 months
measure: Assisted Primary Patency at 24 Months
timeFrame: 24 months
measure: Access Secondary Patency at 6 Months
timeFrame: 6 months
measure: Access Secondary Patency [12 Months] Units Percentage of Subjects
timeFrame: 12 months
measure: Access Secondary Patency [24 Months] Units Percentage of Subjects
timeFrame: 24 months
measure: Circuit Primary Patency
timeFrame: 6 months
measure: Circuit Primary Patency [12 Months] Units Percentage of Subjects
timeFrame: 12months
measure: Circuit Primary Patency [24 Months] Units Percentage of Subjects
timeFrame: 24 months
measure: Clinical Success
timeFrame: Following Index Procedure
measure: Anatomic Success
timeFrame: Index Procedure
measure: Procedural Success
timeFrame: Following Index Procedure
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Fresno
country: United States
state: California
city: Inglewood
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: New Haven
country: United States
state: Connecticut
city: Jacksonville
country: United States
state: Florida
city: Albany
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Des Moines
country: United States
state: Iowa
city: Louisville
country: United States
state: Kentucky
city: Baltimore
country: United States
state: Maryland
city: New Brighton
country: United States
state: Minnesota
city: St. Paul
country: United States
state: Minnesota
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Dayton
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Beaumont
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Winchester
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Spokane
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
affiliation: Vascular Access Center; Frontenac, MO
name: Tom Vesely, MD
role: STUDY_DIRECTOR
References:
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.