Drug Eluting Balloon Angioplasty for Dialysis Access Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SIABLIS DIMITRIOS, University of Patras
ClinicalTrials.gov Identifier:
NCT01174472
First received: July 21, 2010
Last updated: January 20, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Dialysis
Angioplasty
Device: Percutaneous Transluminal Angioplasty (PTA)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Drug Eluting Versus Conventional Balloon Angioplasty for the Treatment of Failing Dialysis Access. A Prospective Randomized Single-Center Trial.

Resource links provided by NLM:


Further study details as provided by University of Patras:

Primary Outcome Measures:
  • Technical success [ Time Frame: 1 minute after the final balloon angioplasty ] [ Designated as safety issue: Yes ]
    Residual stenosis of the treated lesion less than 30%, without any hemodynamicaly significant dissection (Type C)after the final angiography

  • Primary patency [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Secondary patency [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Target lesion re-intervention (TLR)-free interval [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The time interval without any additional recanalization procedure within the area of the treated lesion, because of angiographic or/and clinical deterioration

  • Major complications rates [ Time Frame: Periprocedural and up to 1 year ] [ Designated as safety issue: Yes ]
    Classified according to published international guidelines and reporting standards

  • Minor complications rates [ Time Frame: Periprocedural and up to 1 year follow-up ] [ Designated as safety issue: Yes ]
    Classified according to published international guidelines and reporting standards


Enrollment: 40
Study Start Date: March 2010
Study Completion Date: January 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 conventional angioplasty balloons
Other Name: 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 Name: IN.PACT ADMIRAL, Paclitaxel eluting dilatation PTA catheter

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174472

Locations
Greece
Patras University Hospital, Department of Radiology, Angiography Suite
Rion, Achaias, Greece, 26504
Sponsors and Collaborators
University of Patras
Investigators
Principal Investigator: Dimitrios Siablis, MD, PhD Patras University Hospital
  More Information

No publications provided by University of Patras

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: SIABLIS DIMITRIOS, Professor of Radiology, University of Patras
ClinicalTrials.gov Identifier: NCT01174472     History of Changes
Other Study ID Numbers: 9462/14-4-2010
Study First Received: July 21, 2010
Last Updated: January 20, 2012
Health Authority: Greece: Ethics Committee

Keywords provided by University of Patras:
Dialysis access
angioplasty
drug eluting balloon

Additional relevant MeSH terms:
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014