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Table 2 Inclusion and exclusion criteria

From: BAlloon versus Stenting in severe Ischaemia of the Leg-3 (BASIL-3): study protocol for a randomised controlled trial

Inclusion criteria Exclusion criteria
Have SLI due to atherosclerotic FP, ± IP, PAD Have an anticipated life expectancy <6 months
Be judged by the responsible clinicians (consultant VS, IR) working as part of a MDT to: Require early FP, ± IP, endovascular revascularisation in addition to BMT, foot and wound care Be, in the opinion of the clinician, unable to provide informed consent
Have or will have adequate ‘inflow’ to support all trial revascularisation strategies Be a non-English speaker where local translation facilities are insufficient to guarantee informed consent
Judged suitable for all trial revascularisation strategies following diagnostic imaging and a documented MDT discussion Be judged unsuitable for the endovascular revascularisation strategies by a vascular MDT
Able to complete QoL and resource use booklet Previous intervention (BET or bypass) to the target vessel within the past 12 months
  1. BET best endovascular therapy BMT best medical therapy IP infrapopliteal FP femoro-popliteal MDT multi-disciplinary team PAD peripheral arterial disease, QoL quality of life SLI severe limb ischaemia