Drug-eluting Balloon vs. Conventional Balloon in the Treatment of (re)Stenosis - a Randomized Prospective Study (DRECOREST1)

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Peripheral Artery Occlusive Disease; Peripheral Artery Restenosis; Peripheral Artery Stenosis

Treatments: Device: Conventional PTA; Device: Drug-eluting balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT03023098

DRECOREST1 - Jan 23rd 2013

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 57 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any venous bypass with stenosis warranting intervention

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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57 participants in 2 patient groups

Drug-eluting balloon

Experimental group

Treatment:

Device: Drug-eluting balloon

Conventional PTA

Active Comparator group

Treatment:

Device: Conventional PTA