NCT03036241

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 dialysis fistulae.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

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 23, 2013

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
Last Updated

June 23, 2017

Status Verified

June 1, 2017

Enrollment Period

4.1 years

First QC Date

January 19, 2017

Last Update Submit

June 22, 2017

Conditions

Vascular Access ComplicationRestenosis, Vascular GraftDialysis Related Complications

Keywords

drug-eluting balloon,target lesion revascularization (TLR)restenosis

Outcome Measures

Primary Outcomes (2)

  • TLR

    Target lesion revascularization, ie. re-intervention to the same lesion

    12 months

  • Occlusion of access

    Any loss of dialysis access due to thrombosis

    12 months

Secondary Outcomes (2)

  • Primary assisted patency

    12 months

  • Death

    12 months

Study Arms (2)

Drug-eluting balloon

EXPERIMENTAL
Device: Angioplasty with drug-eluting balloon

Conventional angioplasty

ACTIVE COMPARATOR
Device: Conventional angioplasty

Interventions

Conventional angioplastyDEVICE

Angioplasty with conventional balloon

Also known as: PTA
Conventional angioplasty
Angioplasty with drug-eluting balloonDEVICE

Angioplasty with 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 dialysis access w/ native vessels warranting intervention

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bjorkman P, Weselius EM, Kokkonen T, Rauta V, Alback A, Venermo M. Drug-Coated Versus Plain Balloon Angioplasty In Arteriovenous Fistulas: A Randomized, Controlled Study With 1-Year Follow-Up (The Drecorest Ii-Study). Scand J Surg. 2019 Mar;108(1):61-66. doi: 10.1177/1457496918798206. Epub 2018 Sep 5.

    PMID: 30182815DERIVED

MeSH Terms

Conditions

Graft Occlusion, Vascular

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Maarit Venermo, Prof

    Helsinki University Hospital, dept of vascular surgery

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 19, 2017

First Posted

January 30, 2017

Study Start

January 23, 2013

Primary Completion

February 28, 2017

Study Completion

February 28, 2017

Last Updated

June 23, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share