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Drug Eluting Balloon for Prevention of Hemodialysis Access Restenosis

NCT01928498 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-01-20

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effectiveness of paclitaxel-coated balloon catheter to prevent restenosis after PTA (percutaneous transluminal angioplasty) of hemodialysis access (HA) in comparison with the uncoated PTA balloon catheter.

Conditions

  • Arteriovenous Fistulae
  • Arteriovenous Graft

Interventions

DEVICE

Paclitaxel Eluting Balloon Angioplasty

DEVICE

Percutaneous Transluminal Angioplasty (PTA)

Sponsors & Collaborators

  • Biotronik Canada Inc

    collaborator INDUSTRY

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Éric Therasse, MD · Centre hospitalier de l'Université de Montréal (CHUM)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2020-01-13
Completion
2020-08-27

Countries

  • Canada

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 NCT01928498 on ClinicalTrials.gov