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Table 1 BASIL-2 secondary outcomes

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

Overall survival
In-hospital and 30-day morbidity and mortality
Major adverse limb event – amputation (transtibial and above) or any major vascular re-intervention (thrombectomy, thrombolysis, balloon angioplasty, stenting or surgery)
Major adverse cardiovascular event – (severe limb ischaemia and amputation affecting the contralateral limb, acute coronary syndrome, or stroke)
Relief of ischaemic pain (visual analogue scale and medication usage)
Psychological morbidity (Hospital Anxiety and Deprivation Score)
Quality of life using generic (European Quality of life 5 level questionnaire, Short Form-12, ICEpop CAPability for older people and disease specific Vascular Quality of Life) tools
Re- and cross-over intervention rates
Healing of tissue loss (ulcers, gangrene) of presumed arterial aetiology as assessed by the Perfusion Extent Depth Infection Sensation [6] and Wound Ischaemia Foot Infection [7] scoring and classification systems
Extent and healing of minor (toe and forefoot) amputations (also using the above wound scoring systems)
Haemodynamic changes: absolute ankle and toe pressure, (ankle brachial pressure index and toe brachial pressure index).