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Completed

NCT Number: NCT01174472

Drug Eluting Balloon Angioplasty for Dialysis Access Treatment

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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Key information

Conditions

Dialysis Angioplasty

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Patras University Hospital, Department of Radiology, Angiography Suite

Rio, Achaias, 26504, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous Transluminal Angioplasty (PTA)

Device

Angioplasty performed with the use of the novel paclitaxel eluting balloons

Other names: IN.PACT ADMIRAL, Paclitaxel eluting dilatation PTA catheter

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. Major complications rates

    Time frame: Periprocedural and up to 1 year

    Classified according to published international guidelines and reporting standards

  4. Minor complications rates

    Time frame: Periprocedural and up to 1 year follow-up

    Classified according to published international guidelines and reporting standards

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2012
First posted
Aug 3, 2010
Registry last updated
Jan 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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