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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