Renal Failure
Conditions
Keywords
Hemodialysis, Fistula, Angiograph, Angiogram
Brief 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.
Interventions
The 'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface' will be deployed at the brachiocephalic stenosis.
Subject will receive standard of care PTA alone at the brachiocephalic stenosis without deployment of the'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface'
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. * The patient has lesions that meet the angiographic inclusion /
Exclusion criteria
and induce clinical, hemodynamic or functional abnormality.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target lesion primary patency at 3, 6, and 12 months | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 1 year |
Countries
Canada
Outcome results
None listed