NCT01200914

Covered Stents to Treat Hemodialysis Access Stenoses in the Cephalic Arch and Central Veins

Placement of Covered Stents to Treat Hemodialysis Access Stenosis in the Cephalic Arch and Central Veins

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Balloon angioplasty is used to open up a narrowing that forms in hemodialysis fistula. Two areas of particular problems are the terminal portion of the cephalic vein near the shoulder and the central veins in the chest. Although angioplasty is standard of care the treated narrowed segments of vein mostly renarrow within 3 months requiring retreatment to keep your dialysis access functional. Recently there has been introduction of a new technology called a covered stent graft. Initial studies suggest that placing this device across the area of narrowing leads to dialysis access staying open longer and needing less angioplasty treatments. This study is designed to compare angioplasty (standard of care) versus using a covered stent graft. The investigators will then look at the dialysis records and future fistulograms to see if there is decreased flow through the fistula at 3, 6 and 12 months after the initial procedure.

Detailed description

This is a randomized, prospective, unblinded study with 1:1 randomization. Both groups will undergo PTA of stenotic lesion and patients will be randomized such that 50% will receive a covered stent in addition to the PTA. Patients will be followed at 3, 6, and 12 months post-procedure. Follow-up will be conducted with either angiographic and/or transonic measurements.

Conditions

• Renal Failure

Interventions

Type	Name	Description
DEVICE	GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface	The 'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface' will be deployed at the brachiocephalic stenosis.
PROCEDURE	PTA alone without use of the GORE VIABAHN	Subject will receive standard of care PTA alone at the brachiocephalic stenosis without deployment of the'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface'

Timeline

• Start date: 2011-01-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2010-09-14
• Last updated: 2016-05-12

Locations

1 site across 1 country: Canada