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Prospective Randomized Trial Comparing DEB Versus Conventional PTA for the Treatment of Hemodialysis AVF or AVG Stenoses

NCT01544907 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2017-11-06

No results posted yet for this study

Summary

A prospective randomized trial comparing the efficacy of drug eluting balloon angioplasty versus conventional percutaneous transluminal angioplasty balloon for the treatment of hemodialysis arterio-venous fistula or arterio-venous graft stenoses in reducing late luminal loss and restenosis rates, while prolonging primary and secondary patencies.

Conditions

  • Stenosis of Arteriovenous Dialysis Fistula
  • Arteriovenous Graft Stenosis

Interventions

DEVICE

Conventional PTA

Use of conventional balloon for angioplasty only

DEVICE

Drug Eluting Balloon (DEB)

Use of DEB after conventional balloon angioplasty

Sponsors & Collaborators

  • National Medical Research Council (NMRC), Singapore

    collaborator OTHER_GOV

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Farah G Irani, MBBS,FRCR · Singapore General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01544907 on ClinicalTrials.gov