Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Artery Occlusive Disease
- Sponsor
- Helsinki University Central Hospital
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- TLR (Target lesion revascularization)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Maarit Venermo
Professor of Vascular Surgery
Helsinki University Central Hospital
Eligibility Criteria
Inclusion Criteria
- •Any venous bypass with stenosis warranting intervention
Exclusion Criteria
- •Previous PTA with drug-eluting balloon, thrombolysis, coagulopathy
Outcomes
Primary Outcomes
TLR (Target lesion revascularization)
Time Frame: 12 months
Any reintervention to the same lesion.
Graft occlusion
Time Frame: 0-12 months
Occlusion of the bypass graft
Secondary Outcomes
- Major amputation(0-12 months)
- Death(0-12 months)