Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study
Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study
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.
Inclusion Criteria:

 -  Any venous bypass with stenosis warranting intervention

 Exclusion Criteria:

 -  Previous PTA with drug-eluting balloon, thrombolysis, coagulopathy