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Restenosis Following Paclitaxel Eluting Balloon Angioplasty of Hemodialysis Access Stenosis

NCT ID: NCT01001676

Last Updated: 2014-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-07-31

Brief Summary

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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

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Conditions

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Renal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conventional Balloon Angioplasty

Group Type ACTIVE_COMPARATOR

Percutaneous Transluminal Angioplasty (PTA)

Intervention Type DEVICE

Angioplasty with the use of Conventional balloon

Drug Eluting Balloon Angioplasty

Group Type EXPERIMENTAL

Paclitaxel Eluting Balloon Angioplasty

Intervention Type DEVICE

Angioplasty with the use of paclitaxel eluting balloon

Interventions

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Percutaneous Transluminal Angioplasty (PTA)

Angioplasty with the use of Conventional balloon

Intervention Type DEVICE

Paclitaxel Eluting Balloon Angioplasty

Angioplasty with the use of paclitaxel eluting balloon

Intervention Type DEVICE

Other Intervention Names

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Passeo-18 Lux (Biotronik)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kong Teng Tan, BCh MB

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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ktt1

Identifier Type: -

Identifier Source: org_study_id