Drug Eluting Balloon Angioplasty for Dialysis Access Treatment

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/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-01-31

Brief Summary

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The aim of the study is to compare the feasibility and the effectiveness, by means of immediate and long-term results, of drug eluting balloon (DEB) versus conventional balloon angioplasty for the treatment of failing dialysis access.

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Detailed Description

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In total 40 patients already diagnosed with hemodynamically significant stenosis of the dialysis AVF or AVG (including venous outflow lesions), programmed to undergo percutaneous transluminal angioplasty by our department, will sign informed consent and will be randomized to either receive DEB (Paclitaxel eluting balloon), or conventional balloon therapy. The protocol includes the description of patient's demographics (age, gender,dialysis access details, risk factors) and procedural details, as well as immediate results and long-term follow up.

Conditions

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Dialysis Angioplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Conventional Balloon Angioplasty (COBA)

Patients with lesions treated with conventional balloon angioplasty

Group Type ACTIVE_COMPARATOR

Percutaneous Transluminal Angioplasty (PTA)

Intervention Type DEVICE

Angioplasty performed with the use of conventional angioplasty balloons

Drug Eluting Balloon Angioplasty (DEB)

Patients with lesions treated with Drug Balloon Angioplasty

Group Type EXPERIMENTAL

Percutaneous Transluminal Angioplasty (PTA)

Intervention Type DEVICE

Angioplasty performed with the use of the novel paclitaxel eluting balloons

Interventions

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Percutaneous Transluminal Angioplasty (PTA)

Angioplasty performed with the use of the novel paclitaxel eluting balloons

Intervention Type DEVICE

Percutaneous Transluminal Angioplasty (PTA)

Angioplasty performed with the use of conventional angioplasty balloons

Intervention Type DEVICE

Other Intervention Names

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IN.PACT ADMIRAL, Paclitaxel eluting dilatation PTA catheter Conquest PTA Balloon Dilatation Catheter

Eligibility Criteria

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Inclusion Criteria

* Angiographic and clinical diagnosis of dysfunctional dialysis access due to one or more stenotic lesions.
* Patients with AVF or AVG
* Fistula or graft or vessel diameter ranging from 3 mm up to 12 mm

Exclusion Criteria

* Fistula or graft or vessel diameter \< 3 mm and \> 12 mm
* History of severe allergic reaction to contrast media
* Intolerance to aspirin and/or clopidogrel
* Systemic coagulopathy or hypercoagulation disorders

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No