NCT00737672

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

GORE VIABAHN® Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise Arteriovenous Grafts at the Venous Anastomosis in Hemodialysis Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 293 (actual)
• Sponsor: W.L.Gore & Associates · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Renal Failure
• Hemodialysis

Interventions

Type	Name	Description
DEVICE	GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface	Deployment of investigational stent graft at the venous anastomosis
PROCEDURE	Percutaneous Transluminal Angioplasty	Percutaneous Transluminal Angioplasty at the venous anastomosis

Timeline

• Start date: 2008-09-01
• Primary completion: 2011-05-01
• Completion: 2013-06-01
• First posted: 2008-08-19
• Last updated: 2014-10-21
• Results posted: 2014-10-21

Locations

31 sites across 1 country: United States