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Completed

NCT Number: NCT03036241

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

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.

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Key information

Conditions

Vascular Access Complication Dialysis Related Complications Graft Occlusion, Vascular Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Restenosis, Vascular Graft

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any dialysis access w/ native vessels warranting intervention

Exclusion criteria

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

Treatment and study plan

Conventional angioplasty

Device

Angioplasty with conventional balloon

Other names: PTA

Angioplasty with drug-eluting balloon

Device

Angioplasty with drug-eluting balloon

Other names: DEB

Primary outcomes

  1. TLR

    Time frame: 12 months

    Target lesion revascularization, ie. re-intervention to the same lesion

  2. Occlusion of access

    Time frame: 12 months

    Any loss of dialysis access due to thrombosis

Secondary outcomes

  1. Primary assisted patency

    Time frame: 12 months

    Patency after endovascular reintervention due to restenosis or thrombosis

  2. Death

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

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

Acronym: DRECOREST2

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jan 30, 2017
Registry last updated
Jun 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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