Renal Failure Clinical Trial
Official title:
Local Delivery of Paclitaxel for Prevention of Restenosis in Hemodialysis Access
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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