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.
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.