BASIL-3 is an individually randomised, multi-centre, pragmatic, three-arm, open label trial of three alternative revascularisation strategies for the management of SLI due to femoro-popliteal disease, incorporating a within-trial economic evaluation and permission for data collection for a subsequent prospective cohort study. BASIL-3 has been closely based on the currently HTA-funded BASIL-2 trial and will utilise the experience and expertise thereby gained by the Chief (CI) and Principal Investigators (PIs).
Severe limb ischaemia patients usually require frequent health care interventions in primary and secondary care after their primary revascularisation. To fully capture this activity, as well as the associated changes in QoL and health resource usage, patients will be closely followed up, especially during the first 12 months after randomisation.
Basil-3 will recruit 861 patients with severe limb ischemia due to femoro-popliteal disease from England, Wales, Scotland, and possibly other EU states over 36 months. Patients will be followed up for an average of just over 3 years after their intervention.
Patients will be randomised, to have either a Plain Balloon Angioplasty with a Bare Metal Stent (if needed) or Drug Coated Balloon with a Bare Metal Stent (if needed) or a Drug Eluting Stent.
Recovery time from endovascular intervention is often prolonged and caring for patients with SLI is extremely costly to NHS and social care services, so patients will be asked to complete questionnaires on their quality of life, attitudes to their life, and the personal impact upon their finances. Wider financial impact will be assessed via a Health Economic Analysis.