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Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study (NCT03023098)

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.
  • Device: Conventional PTA
    After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a conventional balloon
    • PTA (percutaneous transluminal angioplasty)
    • Balloon angioplasty
  • Device: Drug-eluting 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
    • DEB
Ages eligible for Study
all
Genders eligible for Study
All
Accepts Healthy Volunteers
No
Inclusion Criteria:
  • Any venous bypass with stenosis warranting intervention
Exclusion Criteria:
  • Previous PTA with drug-eluting balloon, thrombolysis, coagulopathy
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.

1 locations

Finland (1)
  • Helsinki University Hospital
    Helsinki, Finland, 00029
Status:
completed
Type:
Interventional
Phase:
-
Start:
31 December, 2012
Updated:
12 January, 2017
Participants:
57
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