NCT02368197

Brief Summary

This study is designed to compare the safety and efficacy of paclitaxel-eluting balloon (DEB) versus conventional percutaneous transluminal angioplasty (PTA) for the treatment of hemodynamically significant recurrent cephalic arch stenosis in brachial cephalic fistulas in hemodialysis patients.

Trial Health

57
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Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

December 9, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 20, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

1.8 years

First QC Date

December 9, 2014

Last Update Submit

June 28, 2018

Conditions

Dialysis Access Dysfunction

Keywords

dialysis fistulacephalic arch stenosisballoon angioplastydrug eluting balloon

Outcome Measures

Primary Outcomes (1)

  • Restenosis rate

    Incidence of \>50% stenosis at the treatment site

    6 months

Secondary Outcomes (1)

  • Post intervention lesion patency

    Up to 12 months

Study Arms (2)

Standard balloon angioplasty

ACTIVE COMPARATOR

Dilatation of stenosis with standard non drug eluting balloon catheter

Device: Balloon angioplasty (Bard Dorado)

Drug eluting balloon angioplasty

EXPERIMENTAL

Dilatation of stenosis with paclitaxel eluting balloon catheter

Drug: paclitaxel (Cardionovum Legflow drug eluting balloon)

Interventions

paclitaxel (Cardionovum Legflow drug eluting balloon)DRUG

Elution of paclitaxel from inflated balloon catheter into vessel wall

Also known as: Cardionovum Legflow drug eluting balloon
Drug eluting balloon angioplasty
Balloon angioplasty (Bard Dorado)DEVICE

Dilatation of cephalic arch venous stenosis by radial force applied by a balloon catheter

Also known as: Bard Dorado balloon catheter
Standard balloon angioplasty

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Upper limb dialysis access fistula
  • Angiographically demonstrated cephalic arch stenosis \>50% within 6 months of last angioplasty using a non drug eluting balloon
  • Clinical evidence of hemodynamically significant stenosis: strong pulse and weak thrill on physical exam, prolonged bleeding from puncture sites, raised Kt/V, raised dialysis venous pressure

You may not qualify if:

  • Contrast allergy
  • Unable to give informed consent
  • Cephalic arch stent or stent graft
  • Life expectancy less then 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

Related Publications (3)

  • 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: 22545894BACKGROUND

  • Liistro F, Grotti S, Porto I, Angioli P, Ricci L, Ducci K, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Drug-eluting balloon in peripheral intervention for the superficial femoral artery: the DEBATE-SFA randomized trial (drug eluting balloon in peripheral intervention for the superficial femoral artery). JACC Cardiovasc Interv. 2013 Dec;6(12):1295-302. doi: 10.1016/j.jcin.2013.07.010. Epub 2013 Nov 13.

    PMID: 24239203BACKGROUND

  • Burzotta F, Brancati MF, Trani C, Porto I, Tommasino A, De Maria G, Niccoli G, Leone AM, Coluccia V, Schiavoni G, Crea F. INtimal hyPerplasia evAluated by oCT in de novo COROnary lesions treated by drug-eluting balloon and bare-metal stent (IN-PACT CORO): study protocol for a randomized controlled trial. Trials. 2012 May 6;13:55. doi: 10.1186/1745-6215-13-55.

    PMID: 22559260BACKGROUND

MeSH Terms

Interventions

PaclitaxelAngioplasty, Balloon

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAngioplastyCatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 9, 2014

First Posted

February 20, 2015

Study Start

July 1, 2015

Primary Completion

May 1, 2017

Study Completion

December 1, 2017

Last Updated

July 2, 2018

Record last verified: 2018-06

Locations

IL(1)