Covered Stents to Treat Hemodialysis Access Stenoses in the Cephalic Arch and Central Veins
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.
|Renal Failure||Device: GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface Procedure: PTA alone without use of the GORE VIABAHN|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Placement of Covered Stents to Treat Hemodialysis Access Stenosis in the Cephalic Arch and Central Veins|
- Target lesion primary patency at 3, 6, and 12 months [ Time Frame: 1 year ]
- Target lesion secondary patency at 3, 6, and 12 months, access circuit primary and secondary patency at 3, 6, and 12 months, anatomic, clinical, and procedural success. Adverse events through 1 month [ Time Frame: 1 year ]
|Study Start Date:||January 2011|
|Study Completion Date:||April 2015|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Active Comparator: 'PTA without use of the GORE VIABAHN'
Subjects randomized to 'PTA alone without use of the GORE VIABAHN' will receive the standard of care treatment which is Percutaneous Transluminal Angioplasty without the use of the 'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface'
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'
Experimental: PTA with covered stent
Subjects randomized to PTA with covered stent will receive Percutaneous Transluminal Angioplasty followed by the delivery of a 'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface' .
Device: GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface
The 'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface' will be deployed at the brachiocephalic stenosis.
Other Name: Covered stent
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200914
|Universtiy Health Network|
|Toronto, Ontario, Canada, M5G 2N2|
|Principal Investigator:||Dheeraj Rajan, M.D.||Physician|