Welcome to the BASIL-3 Webpage

Basil-3 completed recruitment on 1 September 2021 with 481 recruits.  Thank you to all our Basil-3 sites and study participants!


Basil-3 is a multi-centre randomised controlled trial of clinical and cost-effectiveness of drug coated balloons, drug eluting  stents, and plain balloon angioplasty with bail-out bare metal stent revascularisation strategies for severe limb ischaemia secondary to femoro-popliteal disease. Severe limb ischemia is the most serious and debilitating form of lower limb peripheral artery disease and is a seriously disabling, life and limb threatening, condition. The aim of BASIL-3 is to evaluate the clinical efficacy and cost-effectiveness of the interventions for people with severe limb ischaemia.

Information about MHRA report on drug eluting devices

Basil-3 suspended recruitment in December 2018 following a meta-analysis published in JAMA regarding trend to increased mortality for PAD patients receiving paclitaxel coated devices.

MHRA published a report in June 2019 recommending that trials involving patients with critical limb ischaemia should consider resuming recruitment.  Following discussion with BASIL-3 funders, the BASIL-3 Data Monitoring Committee and Trial Steering Committee,  it was decided to re-open to recruitment on 16 September 2019.  

You can read more about the pause to recruitment.


Basil 2 & 3 Twitter



 The BASIL-3 Trial is funded by a NIHR Health Technology Assessment grant (project number 13/81/02).