Condition category
Urological and Genital Diseases
Date applied
20/01/2016
Date assigned
20/01/2016
Last edited
20/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Contact information

Type

Public

Primary contact

Mrs Nicola Anderson

ORCID ID

Contact details

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

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 below to request a patient information sheet

Condition

Topic: Renal disorders; Subtopic: Renal disorders; Disease: All Renal disorders

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 measures

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

29/10/2018

Reason abandoned

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

29/10/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

University Hospital Birmingham NHS Foundation Trust

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes