Restenosis Following Paclitaxel Eluting Balloon Angioplasty of Hemodialysis Access Stenosis

University Health Network, Toronto

Status and phase: Completed; Phase 2

Conditions: Renal Failure

Treatments: Device: Paclitaxel Eluting Balloon Angioplasty; Device: Percutaneous Transluminal Angioplasty (PTA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01001676

ktt1

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Conventional Balloon Angioplasty

Active Comparator group

Treatment:

Device: Percutaneous Transluminal Angioplasty (PTA)

Drug Eluting Balloon Angioplasty

Experimental group

Treatment:

Device: Paclitaxel Eluting Balloon Angioplasty