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A combination of smoking, diabetes, high blood pressure, high cholesterol levels, chronic kidney disease and the ageing process, results in some people developing ‘hardening’ of the arteries (atherosclerosis) in their legs. Atherosclerosis can narrow or block lower limb arteries so reducing the blood supply to the legs and feet. If the disease progresses, poor blood supply to the leg can lead to severe pain all the time (ischaemic rest pain), especially at night (ischaemic night pain). At this stage, even minor foot injuries can fail to heal, resulting in the development of tissue loss by ulceration, even gangrene, following infection

The presence of ischaemic rest / night pain, with or without tissue loss, is termed critical or severe limb ischaemia (SLI).

One in every 1000-2000 people in the UK will be diagnosed with SLI each year and the incidence of SLI is rising principally as a result of our ageing population, the increasing numbers of people with diabetes, and high rates of smoking.

Without improvement of the blood supply to the leg and foot, many people affected by SLI will lose their limb and/or die within 12 months.  As well as causing great suffering, SLI places a large economic burden upon health (NHS) and social care services. SLI is a growing global healthcare problem affecting every country in the world.

BASIL-3 will recruit potential patients via a number of recruitment centres throughout the UK and, potentially, the EU. Each centre will be sub-contracted by the University Â鶹¾«Ñ¡ to achieve an agreed level of recruitment from their region.

At the conclusion of any "diagnostic work-up", a group of specialists will decide at a multi-disciplinary team (MDT) meeting if the patient is suitable to enter the trial on the basis of the nature of their SLI and their health in general. If the MDT decides they are suitable, the patient will offered the opportunity to provide consent and participate. Patients may be presented with trial information at any suitable stage in this pathway provided they are made aware that their suitability for the trial is merely a possibility and that the MDT may decide that the trial, for them, may not be the best treatment option.

If a patient is suitable for the trial and does want to participate, then after providing written informed consent they will be randomised to receive an endovascular treatment involving

a balloon being inflated within the diseased vessel (plain balloon angioplasty) with or without a small metal tube (stent)

OR

a drug-coated balloon with or without a stent

OR

a stent which releases a drug slowly into the diseased vessel.

The chance of receiving any one of the treatments will be 1 in 3. Randomisation will be done via a computer and neither the patient or the doctor can choose which treatment a trial patient will receive. 

Information will be collected for all patients regularly for up to seven years (depending on when the patient entered the study).  At the end of this time the information will be analysed to see if either of the treatments that use drugs (coated balloons or stents) are better than a plain balloon with a bare metal stent.

Data will be collected from recruiting centres and direct from participants.  Data will be collected regularly from trial entry: at 1 month, 3 month, 6 month, and then annually until the end of the follow up period (this is 31 August 2023).

To provide robust results, it is important that we collect all the necessary information.  Therefore, we will also be receiving data from NHS England - this will be limited to hospital admissions related to SLI and mortality data and is pseudonymised. This means you cannot be identified from the data we obtain.

You can read more about how we use the data we collect in the BCTU Privacy Notice

The Basil-3 Trial is funded by the NIHR Health Technology Programme, grant number 13/81/02

Patient follow-up will continue until 31 August 2023.  The results of BASIL-3 will be presented at the Charing Cross Symposium on 23 April 2024. A summary of the results will be published on this webpage.