NCT03036241

Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis (Dialysis Fistulae)

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Helsinki University Central Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Vascular Access Complication
• Restenosis, Vascular Graft
• Dialysis Related Complications

Interventions

Type	Name	Description
DEVICE	Conventional angioplasty	Angioplasty with conventional balloon
DEVICE	Angioplasty with drug-eluting balloon	Angioplasty with drug-eluting balloon

Timeline

• Start date: 2013-01-23
• Primary completion: 2017-02-28
• Completion: 2017-02-28
• First posted: 2017-01-30
• Last updated: 2017-06-23