Ask to take part

Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof David Kingsmore
+44 1414515941
clare.dolan3@ggc.scot.nhs.uk


Study Location:

Skip to Main Content
English | Cymraeg
Be Part of Research - Trial Details - Plain balloon angioplasty vs. Viabhan stent graft as a first treatment for narrowing of the veins after receiving a graft for haemodialysis

Plain balloon angioplasty vs. Viabhan stent graft as a first treatment for narrowing of the veins after receiving a graft for haemodialysis

Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Intervention for venous stenosis in arteriovenous grafts


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The kidneys perform a vital function in regulating many chemicals and water in the blood. When the kidneys become diseased, these functions may be affected and if severe enough, can lead to a life-threatening build up of chemicals and water in the body. Whilst a kidney transplant is the ideal treatment for this, most patients with kidney failure require a period of dialysis. Dialysis is where blood is removed from the body, cleaned in a dialysis machine, then returned. A good connection to the machine to allow blood removal and return is the key, and this is called vascular access. Given how important this is, vascular access is often called a patient’s lifeline.
Arteriovenous grafts (AVG) have increasingly been used to provide vascular access for dialysis. The most common problem with AVG is narrowing at the join of the AVG to a vein (venous stenosis). The traditional treatment for venous stenosis is to stretch this narrowed area with a balloon – an angioplasty. Whilst this works well in the short term, the narrowing often comes back and then needs more treatments. A new treatment for venous stenosis has been developed called a stent graft that can be placed at the same time as the angioplasty. The stent graft is a small metal cage, lined by graft material that acts as a support to stop the narrowing from coming back. Several studies have shown that a stent graft can reduce the number of treatments needed but is not clear whether it is better to use them straight away, rather than
wait till after venous stenosis recurs after an angioplasty. The aim of this study is to see which is the best first treatment for venous stenosis – an angioplasty or a stent graft.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

28 Feb 2023 05 Sep 2026

Patients who enter the study will get either an angioplasty or a stent graft as the first treatment for venous stenosis. This decision will be made randomly – like tossing a coin. Both the procedures are standard and commonly done in these centres, each of which has very good outcomes. The researchers will see how the patients get on over the following 18 months, and keep a note of any complications, treatments or admissions to the hospital that happen, and every 3 months ask questions about their vascular access and how they are finding it. From all this information they will be able not only to tell which option works best, but which option patients like best. This information will change how we provide this service not only in this centre, but throughout Europe and the world. It is a very important study.


Patients aged 18 years and over with venous stenosis after receiving a graft for dialysis

You can take part if:



You may not be able to take part if:


1. Pregnant female at the time of informed consent signature.2. AVG implanted less than 4 weeks previously.3. A plan for conversion to alternative form of renal replacement therapy within 60 days.4. A history or evidence of severe systemic disease including:4.1. History of cancer (excludes BCC) with active disease or active anti-tumor (cytotoxic) treatment within the previousyear;4.2. Suspected or documented hyper-coagulable state, unless willing to take anti-coagulation;4.3. Recurrent (>1/year) unexplained thrombotic episodes;5. Known or suspected central vein stenosis / occlusion on the side of AVG.6. Treatment with any investigational drug within 60 days prior to study entry.7. Any condition that in the judgment of the investigator would preclude adequate evaluation of the trial end points.8. Unwilling or unable to have regular surveillance.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • NHS Greater Glasgow and Clyde
    J B Russell House Gartnavel Royal Hospital 1055 Great Western Road Glasgow
    Glasgow
    G12 0XH
  • Cardiff & Vale University Lhb
    Woodland House Maes-y-coed Road
    Cardiff
    CF14 4HH
  • St Thomas's Hospital
    249 Westminster Bridge Road
    London
    SE1 7EH
  • Queen Elizabeth University Hospital
    Department of Vascular Surgery
    Glasgow
    G51 4TF
  • The Royal London Hospital
    Whitechapel Road Whitechapel
    London
    E1 1BB
  • Insubria University Hospital
    Department of Vascular Surgery and Department of Surgical Sciences Via Ravasi, 2
    Varese
    21100

Patients will not receive any direct benefit from the study, but we hope the study will help doctors to provide the best treatment in the future. Both treatments in this study are already performed as standard of care. There are no additional risks in taking part in this study over and above those experienced in clinical care.


The study is sponsored by NHS Greater Glasgow and Clyde and funded by Kidney Research UK.





We'd like your feedback

Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.


Is this study information helpful?

What will you do next?

Read full details for Trial ID: ISRCTN47220776

Or CPMS 54767

Last updated 13 February 2023

This page is to help you find out about a research study and if you may be able to take part

You can print or share the study information with your GP/healthcare provider or contact the research team directly.