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Drug-Eluting Balloon in Arteriovenous Graft

NCT03388892 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2018-11-23

No results posted yet for this study

Summary

The investigators' study aims is to evaluate the safety and efficacy of percutaneous transluminal angioplasty (PTA) with paclitaxel-coated balloon (PCB) at venous anastomotic stenosis of arteriovenous graft (AVG) in patients with hemodialysis

Conditions

  • Kidney Failure, Chronic
  • Angioplasty
  • Dialysis

Interventions

DEVICE

paclitaxel-coated balloon, IN. PACT(Invatec-Medtronic, Brescia, Italy)

Arteriovenous graft (AVG) dysfunction or acute thrombosis is mainly caused by neointimal hyperplasia. Although endovascular intervention, such as percutaneous transluminal angioplasty (PTA), catheter-based directed thrombolysis with urokinase, mechanical thrombectomy with percutaneous thrombolytic device or even if graft stenting, can salvage the hemodialysis access, the long-term primary and secondary patent rate don't improve due to repeated restenosis from neointimal hyperplasia. Drug eluting balloon is used in reducing neointimal hypoplasia in patients with coronary in-stent restenosis and it's also effective in restenosis of peripheral arterial diseases. It's reasonable to hypothesize that PTA with PCB at venous anastomotic stenosis of AVG could prolong the patency and reduce the acute thrombosis rate.

DEVICE

Plain Balloon

Traditional Plain Balloon was used to dilate the venous anastomotic stenosis of arteriovenous graft (AVG) as the usual intervention

Sponsors & Collaborators

  • National Taiwan University Hospital Hsin-Chu Branch

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-01-29
Primary Completion
2017-07-25
Completion
2018-11-20

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 NCT03388892 on ClinicalTrials.gov