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Table 1 Secondary outcome measures

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

Overall survival  
Major adverse limb events (MALE), defined as amputation (transtibial or above) or any major vascular re-intervention (thrombectomy, thrombolysis, PBA, stenting, or surgery)  
In-hospital and 30-day morbidity and mortality  
Major adverse cardiac events (MACE), defined as SLI and amputation affecting the contralateral limb, ACS, or stroke  
Relief of ischaemic pain (VAS, medication usage)  
Psychological morbidity (using HADS)  
Quality of life using generic (EQ-5D-5L, ICECAP-O, SF-12) and disease-specific (VascuQoL) tools  
Re- and cross-over intervention rates  
Healing of tissue loss (ulcers, gangrene) as assessed by the PEDIS and the WIFI scoring and classification systems  
Extent and healing of minor (toe and forefoot) amputations (also using PEDIS and WIFI)  
Haemodynamic changes; absolute ankle and toe pressures, ABPI, TBPI  
  1. ABPI ankle-brachial pressure index, PBA plain balloon angioplasty, EQ-5D-5L European quality of life 5 level score, HADS Hospital Anxiety and Depression Scale, ICECAP-O ICEpop CAPability measure for Older people, PEDIS Perfusion Extent Depth Ischaemia Sensation, SF-12 Short form-12 health survey version 2, TBPI toe-brachial pressure index, VAS Visual Analogue Scale, WIFI Wound, Ischaemia, and Foot Infection tool