Drug Eluting Balloon Angioplasty for Dialysis Access Treatment

January 20, 2012 updated by: SIABLIS DIMITRIOS, University of Patras

Drug Eluting Versus Conventional Balloon Angioplasty for the Treatment of Failing Dialysis Access. A Prospective Randomized Single-Center Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Achaias
      • Rion, Achaias, Greece, 26504
        • Patras University Hospital, Department of Radiology, Angiography Suite

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Balloon Angioplasty (COBA)
Patients with lesions treated with conventional balloon angioplasty
Device: Percutaneous Transluminal Angioplasty (PTA)
Angioplasty performed with the use of the novel paclitaxel eluting balloons
Other Names:
  • IN.PACT ADMIRAL, Paclitaxel eluting dilatation PTA catheter
Device: Percutaneous Transluminal Angioplasty (PTA)
Angioplasty performed with the use of conventional angioplasty balloons
Other Names:
  • Conquest PTA Balloon Dilatation Catheter
Experimental: Drug Eluting Balloon Angioplasty (DEB)
Patients with lesions treated with Drug Balloon Angioplasty
Device: Percutaneous Transluminal Angioplasty (PTA)
Angioplasty performed with the use of the novel paclitaxel eluting balloons
Other Names:
  • IN.PACT ADMIRAL, Paclitaxel eluting dilatation PTA catheter
Device: Percutaneous Transluminal Angioplasty (PTA)
Angioplasty performed with the use of conventional angioplasty balloons
Other Names:
  • Conquest PTA Balloon Dilatation Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: 1 minute after the final balloon angioplasty
Residual stenosis of the treated lesion less than 30%, without any hemodynamicaly significant dissection (Type C)after the final angiography
1 minute after the final balloon angioplasty
Primary patency
Time Frame: 1 year
Angiographic visualization of a lesion with <50% restenosis and no need for any additional repeat interventional procedure within the previously treated lesion, due to failing access.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary patency
Time Frame: 1 year
Angiographicaly proven patency (<50% restenosis and no need for any additional repeat interventional procedure within the previously treated lesion, due to failing access)of the treated lesion following one re-intervention procedure of any kind.
1 year
Target lesion re-intervention (TLR)-free interval
Time Frame: 1 year
The time interval without any additional recanalization procedure within the area of the treated lesion, because of angiographic or/and clinical deterioration
1 year
Major complications rates
Time Frame: Periprocedural and up to 1 year
Classified according to published international guidelines and reporting standards
Periprocedural and up to 1 year
Minor complications rates
Time Frame: Periprocedural and up to 1 year follow-up
Classified according to published international guidelines and reporting standards
Periprocedural and up to 1 year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Patras

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

July 21, 2010

First Submitted That Met QC Criteria

August 2, 2010

First Posted (Estimate)

August 3, 2010

Study Record Updates

Last Update Posted (Estimate)

January 23, 2012

Last Update Submitted That Met QC Criteria

January 20, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9462/14-4-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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