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Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis (Dialysis Fistulae) — DRECOREST2  

Vascular Access Complication Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03036241
Study type Interventional
Source Helsinki University Central Hospital
Contact
Status Completed
Phase N/A
Start date January 23, 2013
Completion date February 28, 2017
View Details
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