Renal Failure
Conditions
Keywords
renal failure, Restenosis, Dialysis access, Paclitaxel, Angioplasty, Intimal hyperplasia
Brief summary
Introduction: Narrowing of the draining vein occurs in \>50% of hemodialysis fistula and left untreated will lead to loss of access. The narrowing is due to excessive growth of tissue in the vessel wall (intimal hyperplasia). The standard treatment is balloon dilatation. However, narrowing will inevitably recur in 2-3 months hence requiring further dilatation. Intimal hyperplasia also occurs in the heart and leg circulation. The drug paclitaxel has been used with great success in preventing intimal hyperplasia in these vessels following balloon dilatation. Administer locally, paclitaxel inhibits excess tissue growth in the vessel wall. The investigators believe that this drug will have similar effect in hemodialysis access.. Objective: To assess the effect of paclitaxel in hemodialysis access with narrowing. Paclitaxel is delivered by a paclitaxel-coated balloon. This balloon dilates the narrow segment and simultaneously delivers paclitaxel to the vessel wall. Methodology: Patients with narrowed hemodialysis access are dilated with the paclitaxel-coated balloon or conventional balloon in randomized manner. The patency of the two groups are evaluated and compared at 6 months follow-up. Potential benefit: Decrease number of balloon dilatations and hence hospital admissions, improve dialysis fistula function, and decrease overall economic cost.
Interventions
Angioplasty with the use of Conventional balloon
Angioplasty with the use of paclitaxel eluting balloon
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 access located in the forearm or upper arm * Patient with clinical or hemodynamic evidence of graft dysfunction * Hemodialysis access is \> 3 months old
Exclusion criteria
* Intervention of the vascular access circuit within the past 30 days * Thrombosed/clotted access * Evidence of systemic infection or a local infection associated with the graft * Positive pregnancy test within 7 days before enrolment * Patient is scheduled for a kidney transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary patency | at 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Transonic blood flows | monthly for up to 6 months |
Countries
Canada
Outcome results
None listed