Drug eluting balloon venoplasty in arterio-­venous fistula stenosis

ISRCTN ISRCTN14567609
DOI https://doi.org/10.1186/ISRCTN14567609
ClinicalTrials.gov number NCT02902094
Secondary identifying numbers 20313
Submission date
20/01/2016
Registration date
20/01/2016
Last edited
11/10/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Chronic kidney disease (CKD) is a long-term condition where the kidneys do not work properly. In a healthy person, the kidneys are responsible for filtering out the waste products and excess water in the blood, and converting them into urine. In patients suffering from CKD, the kidneys are unable to do this, and so the body is unable to get rid of the waste products building up in the blood. Haemodialysis is one of the most common treatments for CKD patients, and involves diverting the blood into an external machine so that it can be “cleaned”, before being returned to the body. It requires direct access to the circulatory system (blood stream) and the best option for this is a by creating an arterio-venous fistula (AVF), which is made by surgically joining an artery and a vein in the arm. AVFs have a limited lifespan, and over time can become narrowed (stenosed) or blocked (thrombosed). The fistula can be used for haemodialysis again if it is “re-opened”. This is done by inflating a small balloon inside the fistula to flatten any blockages against the artery wall (fistuloplasty). In many cases however, the fistula re-narrows and becomes blocked again (restenosis). New techniques have been developed where the balloon used in the fistuloplasty is coated in a drug, such as Paclitaxel (drug-eluting balloon, DEB). This drug slows the growth of new smooth muscle cells in the vessel wall that may lead to re-narrowing (restenosis). The aim of this study is to find out whether a DEB is more effective than standard balloons (with no drug coating) at slowing down and preventing restenosis.

Who can participate?
Adults who have a narrowed AVF, which has been in use for at least 1 month.

What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group receive the standard fistuloplasty procedure, in which a plain balloon is inflated until the fistula becomes wide enough to become usable. Participants in the second group receive the standard fistuloplasty procedure, in which a balloon coated in a drug called paclitaxel is used. Participants attend follow-up appointments 3, 6 and 12 months after their operation so that the openness (patency) of the fistula can be monitored.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Queen Elizabeth Hospital, Birmingham (UK)

When is the study starting and how long is it expected to run for?
January 2016 to October 2018

Who is funding the study?
Boston Scientific Corporation (USA)

Who is the main contact?
Dr Rob Jones, robert.jones@uhb.nhs.uk

Contact information

Dr Robert Jones
Scientific

Imaging Department
University Hospitals Birmingham NHS Foundation Trust
Queen Elizabeth Hospital Birmingham
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom

ORCiD logoORCID ID 0000-0003-2385-4298
Phone +44 (0)121 3712312
Email robert.jones@uhb.nhs.uk

Study information

Study designRandomised; Interventional; Design type: Treatment
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleImproving outcomes in fistula intervention: A prospective, patient blinded, phase III, randomised controlled trial of drug eluting balloons in the angioplasty of native haemodialysis access arterio-venous fistula outflow stenosis
Study acronymDeVA
Study objectivesThe aim of this study is to investigate whether the use of drug eluting balloons (DEB's) during angioplasty can reliably reduce the rate of re­stenosis.
Ethics approval(s)First Medical Research Ethics Committee, 05/11/2015, ref: 15/EM/0483
Health condition(s) or problem(s) studiedRenal failure
InterventionParticipants are randomised into one of two arms.

Intervention arm: Participants receive a fistuloplasty procedure using a paclitaxel-coated balloon.
Control arm: Participants receive a fistuloplasty procedure using an un-coated balloon.

Participants in both groups are followed up at 3, 6 and 12 months post-fisuloplasty.
Intervention typeOther
Primary outcome measurePresence of at least 50% restenosis of index lesion requiring re-intervention is measured at 3, 6 and 12 months.
Secondary outcome measures1. Fistula failure rate (thrombosis or non-salvageable) is measured at 3, 6 and 12 months
2. Re-intervention rate due to clinical or paraclinical indictions (without 50% restenosis) is measured at 3, 6 and 12 months
Overall study start date15/01/2016
Completion date30/04/2020

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsPlanned Sample Size: 186; UK Sample Size: 186
Total final enrolment92
Key inclusion criteria1. Arteriovenous (AV) fistulas with stenosis requiring percutaneous angioplasty identified on routine diagnostic imaging or causing clinical concern on dialysis
2. Fistula has been in use for at least 1 month and is more than 6 weeks old
3. Brachiocephalic AV fistula
4. Brachiobasilic AV fistula
5. Radiocephalic AV fistula (both proximal and distal)
6. Aged 18 years or over
7. Index lesion is less then the length of the DEB, and the reference vessel diameter is appropriate for treatment with the size range of DEB (4mm ­ 8mm diameter)
8. Capacity to give valid informed consent
Key exclusion criteria1. Allergy to iodinated Intravenous contrast
2. Allergy to Paclitaxel
3. Prosthetic grafts
4. Long or tandem lesions that cannot be treated with a single DEB
5. Thrombosed Arterio­Venous fistulas
6. Women who are breastfeeding, pregnant or intending to become pregnant
7. Participants of child­bearing age who are unwilling to use a reliable form of contraception for the duration of the study
Date of first enrolment15/01/2016
Date of final enrolment30/04/2019

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Queen Elizabeth Hospital
Mindelsohn Way
Edgbaston
Birmingham
B15 2TH
United Kingdom

Sponsor information

University Hospital Birmingham NHS Foundation Trust
Hospital/treatment centre

Renal Department
Queen Elizabeth Hospital
Edgbaston
Birmingham
B15 2TH
England
United Kingdom

ROR logo "ROR" https://ror.org/014ja3n03

Funders

Funder type

Government

Boston Scientific Corporation
Government organisation / For-profit companies (industry)
Alternative name(s)
Boston Scientific, Boston Scientific Corp., BSC
Location
United States of America

Results and Publications

Intention to publish date31/12/2022
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

Editorial Notes

11/10/2021: The following changes have been made:
1. The previous public contact has been removed and replaced with a scientific contact, with the plain English summary updated accordingly.
2. The intention to publish date has been changed from 30/04/2021 to 31/12/2022.
04/10/2021: The NCT number has been added.
22/05/2020: Total final enrolment number added.
08/05/2019: Internal review.
02/04/2019: The condition has been changed from "Topic: Renal disorders; Subtopic: Renal disorders; Disease: All Renal disorders" to "Renal failure" following a request from the NIHR.
21/11/2018: The following changes were made:
1. The publication and dissemination plan was added.
2. The participant level data was added.
07/11/2018: The following changes were made:
1. The recruitment end date was changed from 29/10/2018 to 30/04/2019.
2. The overall trial end date was changed from 29/10/2018 to 30/04/2020.
3. The intention to publish date was changed from 29/10/2019 to 30/04/2021.
31/10/2017: Internal review.