DCB for Dialysis Access Stent Graft Restenosis

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Prosthetic arteriovenous hemodialysis access graft (AVG) has high incidences of venous anastomotic stenosis and access failure. A stent graft can be used in AVG with recurrent venous anastomotic stenosis to improve long-term patency rate. However, after stent graft implementation, the effective treatment for restenosis in a stent graft is still unknown. This randomized trial is designed to evaluate the efficacy and safety of drug-coated balloon versus regular balloon for in-stent restenosis in stent graft. The investigators plan to enroll 40 patients who presented with prosthetic AVG in-stent restenosis, and then to evaluate the restenosis lesions by intravascular ultrasound. Patients will be randomized into two groups of treatment: drug-coated balloon angioplasty or regular balloon angioplasty. ;

Study Design

Related Conditions & MeSH terms

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

Clinical Trial Details

NCT number	NCT03360279
Study type	Interventional
Source	National Taiwan University Hospital Hsin-Chu Branch
Contact	Mu-Yang Hsieh, MD
Phone	886-35326151
Email	h11135@hch.gov.tw
Status	Recruiting
Phase	N/A
Start date	March 5, 2017
Completion date	December 31, 2019

View Details

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