*** The BASIL-3 protocol paper has now been published in "Trials" and can be accessed from their website ***

Introduction 

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.

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

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.

Trial Progress

Basil-3 officialy began its 3-year recruitment phase in February 2016, however due to receiving regulatory approval ahead of schedule, the lead centre (Heart of England NHS Foundation Trust) successfully entered the trial's first two participants during January of 2016. Since then, the trial has managed to meet or exceed each of its monthly targets, which are set by the National Institute for Health Research's HTA programme. This early success has firmly placed the cumulative recruitment total ahead of schedule.

As of 02 October 2017, a total of 33 clinical centres are open to recruit to the Basil-3 trial; 28 in England, 3 in Scotland, and 2 in Wales.  Thirty-two of the 33 clinical centres have cumulatively recruited 238 participants. We have 2 clinical centres which we anticipate will open to recruitment in the next 30 days. Tens of centres have formally expressed interest in opening Basil-3 and are at varying stages of start-up; we anticipate the majority of these opening within the next six months.

You can also see our clinical centres on the map.

The Basil-3 trial team are still accepting expressions of interest from UK-based vascular centres. NHS Trusts in England and Health Boards in the devolved nations should contact the Basil-3 trial office with the name of their proposed Principal Investigator to begin the start-up process for their site. We would typically expect a site Principal Investigator to be a Consultant Interventional Radiologist or a Consultant Vascular Surgeon with prior clinical research experience. Please see the contact us page for details of how to get in touch.

Current Basil-3 Recruitment (as of end of August 2017)

For a more in depth overview of recruitment to Basil-3, visit our recruitment page.