NCT03360279

DCB for Dialysis Access Stent Graft Restenosis

A Randomized Trial Comparing Drug-coated Balloon and Regular Balloon for Dialysis Access Stent Graft Restenosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: National Taiwan University Hospital Hsin-Chu Branch · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-03-05
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2017-12-04
• Last updated: 2017-12-04

Locations

1 site across 1 country: Taiwan