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NCT03036241 Clinical Trial

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

Vascular Access Complication Clinical Trial

— DRECOREST2  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03036241
Other study ID # DRECOREST2 - 23rd Jan 2013
Secondary ID
Status Completed
Phase N/A
First received January 19, 2017
Last updated June 22, 2017
Start date January 23, 2013
Est. completion date February 28, 2017

Study information
Verified date June 2017
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 39
Est. completion date February 28, 2017
Est. primary completion date February 28, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Any dialysis access w/ native vessels warranting intervention

Exclusion Criteria:

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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Conventional angioplasty
Angioplasty with conventional balloon
• Angioplasty with drug-eluting balloon
Angioplasty with drug-eluting balloon

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Helsinki University Central Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary TLR Target lesion revascularization, ie. re-intervention to the same lesion 12 months
Primary Occlusion of access Any loss of dialysis access due to thrombosis 12 months
Secondary Primary assisted patency Patency after endovascular reintervention due to restenosis or thrombosis 12 months
Secondary Death 12 months
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