NCT03023098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 18, 2017

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

3.8 years

First QC Date

January 12, 2017

Last Update Submit

January 13, 2017

Conditions

Peripheral Artery Occlusive DiseasePeripheral Artery RestenosisPeripheral Artery Stenosis

Keywords

RestenosisDrug-eluting balloonVein graft

Outcome Measures

Primary Outcomes (2)

  • TLR (Target lesion revascularization)

    Any reintervention to the same lesion.

    12 months

  • Graft occlusion

    Occlusion of the bypass graft

    0-12 months

Secondary Outcomes (2)

  • Major amputation

    0-12 months

  • Death

    0-12 months

Other Outcomes (1)

  • Primary assisted patency

    0-12 months

Study Arms (2)

Drug-eluting balloon

EXPERIMENTAL
Device: Drug-eluting balloon

Conventional PTA

ACTIVE COMPARATOR
Device: Conventional PTA

Interventions

Conventional PTADEVICE

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

Also known as: PTA (percutaneous transluminal angioplasty), Balloon angioplasty
Conventional PTA
Drug-eluting balloonDEVICE

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

Also known as: DEB
Drug-eluting balloon

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Any venous bypass with stenosis warranting intervention

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Hospital

Helsinki, 00029, Finland

Location

Related Publications (1)

  • Bjorkman P, Kokkonen T, Alback A, Venermo M. Drug-Coated versus Plain Balloon Angioplasty in Bypass Vein Grafts (the DRECOREST I-Study). Ann Vasc Surg. 2019 Feb;55:36-44. doi: 10.1016/j.avsg.2018.04.042. Epub 2018 Aug 6.

    PMID: 30092443DERIVED

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Interventions

AngioplastyAngioplasty, Balloon

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Study Officials

  • Maarit Venermo, M.D., Ph.D.

    Helsinki University Hospital, Dept. of Vascular Surgery

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Vascular Surgery

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 18, 2017

Study Start

January 1, 2013

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

January 18, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)