Text Size

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
History of Changes

July 21, 2010
January 20, 2012
March 2010
December 2010   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01174472 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Drug Eluting Balloon Angioplasty for Dialysis Access Treatment
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.

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Dialysis
  • 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
  • Device: Percutaneous Transluminal Angioplasty (PTA)
    Angioplasty performed with the use of conventional angioplasty balloons
    Other Name: Conquest PTA Balloon Dilatation Catheter
  • Active Comparator: Conventional Balloon Angioplasty (COBA)
    Patients with lesions treated with conventional balloon angioplasty
    Intervention: Device: Percutaneous Transluminal Angioplasty (PTA)
  • Experimental: Drug Eluting Balloon Angioplasty (DEB)
    Patients with lesions treated with Drug Balloon Angioplasty
    Intervention: Device: Percutaneous Transluminal Angioplasty (PTA)
Katsanos K, Karnabatidis D, Kitrou P, Spiliopoulos S, Christeas N, Siablis D. Paclitaxel-coated balloon angioplasty vs. plain balloon dilation for the treatment of failing dialysis access: 6-month interim results from a prospective randomized controlled trial. J Endovasc Ther. 2012 Apr;19(2):263-72.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2012
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
NCT01174472
9462/14-4-2010
No
SIABLIS DIMITRIOS, University of Patras
University of Patras
Not Provided
Principal Investigator: Dimitrios Siablis, MD, PhD Patras University Hospital
University of Patras
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP