Vascular Access Complication, Restenosis, Vascular Graft, Dialysis Related Complications
Conditions
Keywords
drug-eluting balloon,, target lesion revascularization (TLR), restenosis
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.
Interventions
DEVICEConventional angioplasty
Angioplasty with conventional balloon
DEVICEAngioplasty with drug-eluting balloon
Angioplasty with drug-eluting balloon
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Any dialysis access w/ native vessels warranting intervention
Exclusion criteria
* Previous PTA with drug-eluting balloon, thrombolysis, coagulopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TLR | 12 months | Target lesion revascularization, ie. re-intervention to the same lesion |
| Occlusion of access | 12 months | Any loss of dialysis access due to thrombosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary assisted patency | 12 months | Patency after endovascular reintervention due to restenosis or thrombosis |
| Death | 12 months | — |
Outcome results
None listed