Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study (Dialysis Fistulae)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Vascular Access Complication
- Sponsor
- Helsinki University Central Hospital
- Enrollment
- 39
- Primary Endpoint
- TLR
- Status
- Completed
- Last Updated
- 8 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 dialysis fistulae.
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 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.
Investigators
Maarit Venermo
Professor of Vascular Surgery
Helsinki University Central Hospital
Eligibility Criteria
Inclusion Criteria
- •Any dialysis access w/ native vessels warranting intervention
Exclusion Criteria
- •Previous PTA with drug-eluting balloon, thrombolysis, coagulopathy
Outcomes
Primary Outcomes
TLR
Time Frame: 12 months
Target lesion revascularization, ie. re-intervention to the same lesion
Occlusion of access
Time Frame: 12 months
Any loss of dialysis access due to thrombosis
Secondary Outcomes
- Primary assisted patency(12 months)
- Death(12 months)