The purpose of this study is to determine whether the use of drug-eluting balloons is effective in the treatment of (re)stenosis in bypass vein grafts.
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 bypass vein grafts, 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
57
After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a conventional balloon
After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a drug-eluting balloon
Helsinki University Hospital
Helsinki, Finland
TLR (Target lesion revascularization)
Any reintervention to the same lesion.
Time frame: 12 months
Graft occlusion
Occlusion of the bypass graft
Time frame: 0-12 months
Major amputation
Above or below knee amputation of the treated leg
Time frame: 0-12 months
Death
Time frame: 0-12 months
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