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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
PTA alone with no stent used
Covered stent produced by GORE VIABAHN
American Access Care of Queens
Flushing, New York, United States
RECRUITINGAmerican Access Care of Bronx
The Bronx, New York, United States
RECRUITINGAccess Care Physicians of New York
White Plains, New York, United States
RECRUITINGPrimary patency at 3, 6, and 12 months
Target lesion primary patency at 3, 6, and 12 months
Time frame: 1 year
Secondary patency at 3, 6, and 12 months
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
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