Placement of Covered Stents to Treat Hemodialysis Access Stenoses in the Cephalic Arch and Centra… (NCT01271881) | Clinical Trial Compass
UnknownNot Applicable
Placement of Covered Stents to Treat Hemodialysis Access Stenoses in the Cephalic Arch and Central Veins
United States140 participantsStarted 2010-10
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Hemodialysis patient with a mature forearm or upper arm access that was created \> 2 months before enrollment in study.
✓. The patient is ≥ 18 years of age.
✓. The patient has a reasonable expectation of remaining on hemodialysis for 12 months.
✓. The patient or his/her legal guardian understands the study and is willing and able to comply with follow-up requirements.
✓. The patient or his/her legal guardian is willing to provide informed consent.
Exclusion criteria
✕. The patient has a known or suspected systemic infection.
✕. The patient has a known or suspected infection of the hemodialysis access and / or bacteremia.
✕. The patient is currently taking maintenance immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone (\>10 mg per day), cyclosporine, tacrolimus, or cyclophosphamide.