Plain English Summary
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?
Mrs Nicola Anderson
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
20313
Study information
Scientific title
Improving 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
Acronym
DeVA
Study hypothesis
The 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
First Medical Research Ethics Committee, 05/11/2015, ref: 15/EM/0483
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Renal failure
Intervention
Participants 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 type
Other
Phase
Phase III
Drug names
Primary outcome measure
Presence of at least 50% restenosis of index lesion requiring re-intervention is measured at 3, 6 and 12 months.
Secondary outcome measures
1. 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 trial start date
15/01/2016
Overall trial end date
30/04/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 186; UK Sample Size: 186
Participant exclusion criteria
1. 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
Recruitment start date
15/01/2016
Recruitment end date
30/04/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queen Elizabeth Hospital
Mindelsohn Way
Edgbaston
Birmingham
B15 2TH
United Kingdom
Funders
Funder type
Government
Funder name
Boston Scientific Corporation
Alternative name(s)
Boston Scientific, Boston Scientific Corp., BSC
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United States of America
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement: The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
30/04/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list