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 of Birmingham 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)
a drug-coated balloon with or without a stent
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 around 3 years after entering the study. At the end of this time the information will be analysed to see if one of the treatments iif either of the treatments that use drugs (coated balloons or stents) are better than a plain balloon with a bare metal stent.