The purpose of this study is to determine whether the use of drug-eluting balloons is effective in the treatment of (re)stenosis in dialysis fistulae.
Drug-eluting devices have proved beneficial in the treatment of stenosis in native coronary and lower limb arteries. Stenosis and restenosis is a known problem in dialysis fistulae and drug-eluting devices might be beneficial in this field as well. In the procedure a conventional balloon is passed through the stenosis which is then dilated. After this patients are randomized before a second dilatation with either a conventional balloon or a drug-coated balloon. The stenosis is evaluated preoperatively and followed up by means of ultrasound by a vascular technician. Follow-up will end at 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
39
Angioplasty with conventional balloon
Angioplasty with drug-eluting balloon
TLR
Target lesion revascularization, ie. re-intervention to the same lesion
Time frame: 12 months
Occlusion of access
Any loss of dialysis access due to thrombosis
Time frame: 12 months
Primary assisted patency
Patency after endovascular reintervention due to restenosis or thrombosis
Time frame: 12 months
Death
Time frame: 12 months
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