NCT01174472

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2010

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 3, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 23, 2012

Status Verified

January 1, 2012

Enrollment Period

9 months

First QC Date

July 21, 2010

Last Update Submit

January 20, 2012

Conditions

DialysisAngioplasty

Keywords

Dialysis accessangioplastydrug eluting balloon

Outcome Measures

Primary Outcomes (2)

  • Technical success

    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

    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 Outcomes (4)

  • Secondary patency

    1 year

  • Target lesion re-intervention (TLR)-free interval

    1 year

  • Major complications rates

    Periprocedural and up to 1 year

  • Minor complications rates

    Periprocedural and up to 1 year follow-up

Study Arms (2)

Conventional Balloon Angioplasty (COBA)

ACTIVE COMPARATOR

Patients with lesions treated with conventional balloon angioplasty

Device: Percutaneous Transluminal Angioplasty (PTA)

Drug Eluting Balloon Angioplasty (DEB)

EXPERIMENTAL

Patients with lesions treated with Drug Balloon Angioplasty

Device: Percutaneous Transluminal Angioplasty (PTA)

Interventions

Percutaneous Transluminal Angioplasty (PTA)DEVICE

Angioplasty performed with the use of the novel paclitaxel eluting balloons

Also known as: IN.PACT ADMIRAL, Paclitaxel eluting dilatation PTA catheter
Drug Eluting Balloon Angioplasty (DEB)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Patras University Hospital, Department of Radiology, Angiography Suite

Rio, Achaias, 26504, Greece

Location

Related Publications (2)

  • Kitrou PM, Katsanos K, Spiliopoulos S, Karnabatidis D, Siablis D. Drug-eluting versus plain balloon angioplasty for the treatment of failing dialysis access: final results and cost-effectiveness analysis from a prospective randomized controlled trial (NCT01174472). Eur J Radiol. 2015 Mar;84(3):418-423. doi: 10.1016/j.ejrad.2014.11.037. Epub 2014 Dec 15.

    PMID: 25575743DERIVED

  • 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. doi: 10.1583/11-3690.1.

    PMID: 22545894DERIVED

MeSH Terms

Interventions

Angioplasty

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Officials

  • Dimitrios Siablis, MD, PhD

    University Hospital of Patras

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Radiology

Study Record Dates

First Submitted

July 21, 2010

First Posted

August 3, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2010

Study Completion

January 1, 2012

Last Updated

January 23, 2012

Record last verified: 2012-01

Locations

GR(1)