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Table 2 BASIL-2 inclusion and exclusion criteria

From: Bypass versus angio plasty in severe ischaemia of the leg - 2 (BASIL-2) trial: study protocol for a randomised controlled trial

Inclusion criteria Exclusion criteria
Have severe limb ischaemia due to infra-popliteal, +/− femoropopliteal disease Have an anticipated life expectancy of < 6 months
Be judged by responsible clinicians (consultant vascular surgeon, interventional radiologist, and diabetologists) working as part of a multi-disciplinary team to require early revascularisation in addition to best medical therapy, foot and wound care. Are unable to provide consent due to incapacity
Have adequate inflow to support the randomised infra-popliteal intervention (if not, patients can be randomised to have their allocated infra-popliteal intervention at the same time or after the inflow procedure). Are a non-English speaker where translation services are inadequate to provide informed consent
Be judged suitable for both vein bypass and best endovascular treatment following diagnostic imaging and a formal documented multi-disciplinary team meeting. Are judged unsuitable for either revascularisation strategy by the responsible clinician
  Tissue loss considered to be primarily of venous aetiology