DCB for Dialysis Access Stent Graft Restenosis

National Taiwan University Hospital Hsin-Chu Branch40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

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

Interventions

Regular balloonDEVICE

Randomization: to use regular balloon to treat stent graft restenosis

DCB (paclitaxel-coated balloon)DEVICE

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age of 20 to 90 years on regular hemodialysis at least 3 months * Had stent graft implemented at dialysis vascular access * Angiographic evidence of stenosis within the stent graft or less than 2 cm from the stent graft edge * Clinical evidence of a hemodynamically significant stenosis or thrombosis * Patient is able to provide written informed consent Exclusion Criteria: * Elbow fracture or any disease involve the elbow joint that prohibits the flexion maneuver. * Target lesion cannot be crossed by the guide wire. * Known hypersensitivity to heparin or contrast medium. * Bleeding diathesis. * Patients participating in another clinical trial with interfering with this trial in the past three months. * Untreatable bleeding diathesis. * Other diseases, such as cancer, liver disease, or cardiac insufficiency, which may lead to protocol violations or markedly shorten a patient's life expectancy (less than 3 months). * Patients unable or unwilling to participate this trial. * Pregnancy, lactating woman, non-adult, criminals in sentence, psychiatric patients, research staffs or colleagues are prohibited.

Locations (1)

National Taiwan University Hospital Hsinchu Branch

Hsinchu, Hsinchu City, Taiwan

RECRUITING