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RCT of Paclitaxel DEB Compared to Standard PTA in Dialysis Fistula

NCT02558153 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2020-05-05

No results posted yet for this study

Summary

A multicenter randomized clinical trial of paclitaxel drug-eluting balloon (DEB) versus standard percutaneous transluminal angioplasty (PTA) to reduce restenosis in 150 patients with haemodialysis access stenoses.

Conditions

  • Complication of Hemodialysis
  • Vascular Access Complication

Interventions

DEVICE

DEB, drug eluting balloon

Percutaneous angioplasty performed with a DEB - drug eluting balloon

DEVICE

standard PTA

Percutaneous angioplasty performed with a standard balloon

Sponsors & Collaborators

  • Archer Research

    collaborator INDUSTRY

  • Groene Hart Ziekenhuis

    lead OTHER

Principal Investigators

  • Peter MT Pattynama, MD, PhD · Groene Hart Ziekenhuis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2019-07-03
Completion
2019-07-03

Countries

  • Belgium
  • Netherlands

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 NCT02558153 on ClinicalTrials.gov