Restenosis Following Paclitaxel Eluting Balloon Angioplasty of Hemodialysis Access Stenosis

Phase 2

Completed

• Conditions: Renal Failure
• Interventions: Device: Percutaneous Transluminal Angioplasty (PTA); Device: Paclitaxel Eluting Balloon Angioplasty

• Registration Number: NCT01001676
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-26
• Study First Submitted QC: 2009-10-26
• Study First Posted: 2009-10-27
• Status Verified: 2012-01
• Study Start: 2012-02
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-11-14
• Last Update Posted: 2014-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional Balloon Angioplasty	Percutaneous Transluminal Angioplasty (PTA)	-
Drug Eluting Balloon Angioplasty	Paclitaxel Eluting Balloon Angioplasty	-

Primary Outcome Measures

Name	Time	Method
Primary patency	at 6 months

Secondary Outcome Measures

Name	Time	Method
Transonic blood flows	monthly for up to 6 months

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada