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

Not Applicable

Completed

• Conditions: Restenosis, Vascular Graft; Vascular Access Complication; Dialysis Related Complications
• Interventions: Device: Angioplasty with drug-eluting balloon; Device: Conventional angioplasty

• Registration Number: NCT03036241
• Lead Sponsor: Helsinki University Central Hospital

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.

Study Timeline

• Study Start: 2013-01-23
• Study First Submitted: 2017-01-19
• Study First Submitted QC: 2017-01-26
• Study First Posted: 2017-01-30
• Primary Completion: 2017-02-28
• Study Completion: 2017-02-28
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-22
• Last Update Posted: 2017-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Any dialysis access w/ native vessels warranting intervention

Exclusion Criteria

• Previous PTA with drug-eluting balloon, thrombolysis, coagulopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug-eluting balloon	Angioplasty with drug-eluting balloon	-
Conventional angioplasty	Conventional angioplasty	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Primary assisted patency	12 months	Patency after endovascular reintervention due to restenosis or thrombosis
Death	12 months