Drug-Eluting Balloon in Arteriovenous Graft

NACompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

January 29, 2015

Primary Completion Date

July 25, 2017

Study Completion Date

November 20, 2018

Conditions
Kidney Failure, ChronicAngioplastyDialysis
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

Trial Locations (1)

Unknown

National Taiwan University Hospital Hsinchu Branch, Hsinchu

All Listed Sponsors
lead

National Taiwan University Hospital Hsin-Chu Branch

OTHER

NCT03388892 - Drug-Eluting Balloon in Arteriovenous Graft | Biotech Hunter | Biotech Hunter