Restenosis Following Paclitaxel Eluting Balloon Angioplasty of Hemodialysis Access Stenosis

Renal Failure Clinical Trial

Official title:

Local Delivery of Paclitaxel for Prevention of Restenosis in Hemodialysis Access

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01001676
• Other study ID #: ktt1
• Status: Completed
• Phase: Phase 2
• First received: October 26, 2009
• Last updated: November 14, 2014
• Start date: February 2012
• Est. completion date: July 2014

Study information

• Verified date: January 2012
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Intervention

Device:
• Percutaneous Transluminal Angioplasty (PTA)
Angioplasty with the use of Conventional balloon
• Paclitaxel Eluting Balloon Angioplasty
Angioplasty with the use of paclitaxel eluting balloon

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency		at 6 months	No
Secondary	Transonic blood flows		monthly for up to 6 months	No