BANNER_B3

Frequently Asked Questions

This section will be updated in an ongoing manner. Trial investigators can submit their questions relating to the conduct of Basil-3 to the trial office.

We are getting a number of queries from centres where they have a patient whom they are considering for BASIL-3 but in whom they may not want to treat all of the femoro-popliteal disease with the allocated treatment. Specifically, there is concern that if a patient is randomised to drug eluting stent (DES), for good clinical and economic reasons, they may not want to "full metal jacket" (FMJ) the whole of the disease in SFA / PA with DES (or indeed a BMS).

As we see it, the key questions is "is there equipoise in respect which treatment is best for the index lesion or lesions (to be defined by the responsible clinician) in the femoro-popliteal segment".
 
If there is, then we think it is appropriate to randomise the patient and use the allocated treatment for the index lesion(s).
If there are other femoro-popliteal (and/or infra-popliteal) lesions which (may) need to be treated at the same time then we think it should be a matter of clinical judgement as to whether they should be treated and how they should be treated (whether by the allocated treatment or not).
 
The only proviso is that if a patient is randomised to non-drug technology, the non-index (accessory) lesions should not be treated with a drug technology, and vice versa.
In practice we feel that in the great majority of such cases the patient will have been randomised to DES.
In such DES case, we would ask that accessory lesions, which are thought unsuitable for stenting, be treated with plain balloon angioplasty (PBA).

In the other two arms, which are "PBA +/- bare metal stent (BMS) as clinically indicated" and "drug coated balloon )DCB +/- BMS as clinically indicated" this is much less of an issue (maybe a non-issue in fact) as we would expect "accessory" lesions (not considered suitable for stenting) to be treated with the allocated treatment (i.e either PBA or DCB as per randomisation).
So, in reality it may only be an issue if the patient is randomised to DES.
We will, of course, be collecting in great detail exactly what treatments each person has had.
 
If we insist that the whole of FP segment is treated with DES (or indeed any stent) then it will inhibit randomisation.
More importantly, it does not reflect real world practice (i.e we do not FMJ very often, if at all).
As such, if we do not adopt this pragmatic "real world" approach to the DES arm the trial will not be helpful / impact practice for the benefit of patient.

If randomised to the primary stenting (DES) arm of the trial, may I pre-dilate the index segment(s)?

Yes. Furthermore, this is recommended procedure according to the DES manufacturers.  

My Basil-3 patient is due for a follow-up session but has a clinical appointment booked at a similar time. What is the tolerance either side of the ideal time points?

Basil-3 is designed to be a pragmatic trial in a group of patients with many co-morbidities. For these reasons, strict tolerances have not been defined for each follow-up time point. We ask our clinical centres to balance the need for regular scheduled follow-up against the burden that would present to their patients. Earlier on in the trial (i.e. 1 month and 6 month follow-up) it is important that the actual dates of attendance approximate the ideal dates, however, when patients reach annual follow-up there is a wider tolerance. We acknowledge that our clinical centres are best placed to make this judgement due to the fact that they have face-to-face contact with their trial participants. The Basil-3 trial team is happy to advise regarding this on a case-by-case basis if necessary and can be contacted by the usual methods.