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Completed

NCT Number: NCT03023098

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

The purpose of this study is to determine whether the use of drug-eluting balloons is effective in the treatment of (re)stenosis in bypass vein grafts.

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Key information

Conditions

Peripheral Artery Occlusive Disease Peripheral Arterial Occlusive Disease 1 Peripheral Artery Restenosis Peripheral Artery Stenosis

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital

Helsinki, 00029, Finland

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 bypass vein grafts, 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 venous bypass with stenosis warranting intervention

Exclusion criteria

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

Treatment and study plan

Conventional PTA

Device

After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a conventional balloon

Other names: PTA (percutaneous transluminal angioplasty), Balloon angioplasty

Drug-eluting balloon

Device

After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a drug-eluting balloon

Other names: DEB

Primary outcomes

  1. TLR (Target lesion revascularization)

    Time frame: 12 months

    Any reintervention to the same lesion.

  2. Graft occlusion

    Time frame: 0-12 months

    Occlusion of the bypass graft

Secondary outcomes

  1. Major amputation

    Time frame: 0-12 months

    Above or below knee amputation of the treated leg

  2. Death

    Time frame: 0-12 months

Other outcomes

  1. Primary assisted patency

    Time frame: 0-12 months

    Patency of the graft after TLR

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Acronym: DRECOREST1

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jan 18, 2017
Registry last updated
Jan 18, 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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