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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03023098

Acronym

DRECOREST1

Enrollment

Registered

2017-01-18

Start date

2013-01-31

Completion date

2016-11-30

Last updated

2017-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Artery Occlusive Disease, Peripheral Artery Restenosis, Peripheral Artery Stenosis

Keywords

Restenosis, Drug-eluting balloon, Vein graft

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 bypass vein grafts.

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 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.

Interventions

DEVICEConventional PTA

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

DEVICEDrug-eluting balloon

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Any venous bypass with stenosis warranting intervention

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
TLR (Target lesion revascularization)	12 months	Any reintervention to the same lesion.
Graft occlusion	0-12 months	Occlusion of the bypass graft

Secondary

Measure	Time frame	Description
Major amputation	0-12 months	Above or below knee amputation of the treated leg
Death	0-12 months	—

Other

Measure	Time frame	Description
Primary assisted patency	0-12 months	Patency of the graft after TLR

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026