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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
44
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.
Traditional Plain Balloon was used to dilate the venous anastomotic stenosis of arteriovenous graft (AVG) as the usual intervention
National Taiwan University Hospital Hsinchu Branch
Hsinchu, Taiwan
patent rate in percentage after PTA
Late luminal loss in patients was evaluated by quantitative angiography after PTA and intravascular ultrasound (IVUS) up to 12 months after PTA. Late luminal loss is defined as the difference between the minimal lumen diameter in percentage and the late luminal loss less than 50% was defined as patency.
Time frame: 1 year
The incidence of angiography-guided binary restenosis rate (≥50% of the diameter of the reference-vessel)
Measure the stenotic percentage every 2 months up to 1 year for angiography
Time frame: 1 year
The incidence of IVUS-guided binary restenosis rate (≥50% of the diameter of the reference-vessel)
Measure the stenotic percentage 1, 6, 12 months for IVUS
Time frame: 1 year
Change of AVG flow in liter per minute
measure the AVG flow and pressure before PTA, 1 week and every 2 months up to 1 year after PTA
Time frame: 1 year
Change of AVG pressure in mmHg
measure the AVG flow and pressure before PTA, 1 week and every 2 months up to 1 year after PTA
Time frame: 1 year
Time interval of patent AVG after PTA
Patent AVG was defined as luminal loss less than 50%
Time frame: 1 year
The rate of AVG failure at 6 months and 12 months
AVG failure was defined as AVG thrombosis, AVG re-intervention
Time frame: 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.