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

Not Applicable

Completed

• Conditions: Peripheral Artery Stenosis; Peripheral Artery Occlusive Disease; Peripheral Artery Restenosis
• Interventions: Device: Drug-eluting balloon; Device: Conventional PTA

• Registration Number: NCT03023098
• Lead Sponsor: Helsinki University Central Hospital

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-01
• Study First Submitted: 2017-01-12
• Study First Submitted QC: 2017-01-13
• Last Update Submitted: 2017-01-13
• Study First Posted: 2017-01-18
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Any venous bypass with stenosis warranting intervention

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug-eluting balloon	Drug-eluting balloon	-
Conventional PTA	Conventional PTA	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Major amputation	0-12 months	Above or below knee amputation of the treated leg
Death	0-12 months

Trial Locations

Locations (1)

Helsinki University Hospital; 🇫🇮 Helsinki, Finland