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DCB for Dialysis Access Stent Graft Restenosis

NCT03360279 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-12-04

No results posted yet for this study

Summary

Recurrent stenosis in hemodialysis access graft (AVG) is difficult to treat. For recurrent stenosis in the anastomotic junction can be treated by stent graft to improve long-term patency. However, there is no data regarding treatment of stent graft restenosis in AVG. This randomized trial is designed to compare the efficacy and safety of drug-coated balloon (DCB) versus regular balloon in AVG stent graft restenosis.

Conditions

  • Hemodialysis Access Failure (Disorder)
  • Stent-Graft Restenosis
  • Arteriovenous Graft
  • Drug-coated Balloon

Interventions

DEVICE

Regular balloon

Randomization: to use regular balloon to treat stent graft restenosis

DEVICE

DCB (paclitaxel-coated balloon)

Randomization: to use DCB (paclitaxel-coated balloon, Ranger, Boston-Scientific) to treat stent graft restenosis. The paclitaxel dose is 2 ug/mm2 delivered with the Ranger drug-coated balloon.

Sponsors & Collaborators

  • National Taiwan University Hospital Hsin-Chu Branch

    lead OTHER

Principal Investigators

  • Mu-Yang Hsieh, MD · National Taiwan University Hospital Hsin-Chu Branch

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-03-05
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Taiwan

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 NCT03360279 on ClinicalTrials.gov