Multicentre randomised controlled trial to compare the clinical and cost-effectiveness of a vein-bypass-first with an endovascular-first revascularisation strategy for severe limb ischaemia (SLI) due to infrageniculate arterial disease

niversity of Birmingham (UK)0 个研究点目标入组 345 人开始时间: 2014年5月12日最近更新: 2023年5月15日

试验速览

•1. Have Severe Limb Ischaemia (SLI) due to infra-popliteal (IP), with or without femoro-popliteal (FP) disease
•2. Be judged by the responsible clinicians (consultant vascular surgeon (VS), interventional radiologist (IR), diabetologists) working as part of a multi-disciplinary team (MDT) to require early infra-popliteal (IP), with or without femoro-popliteal (FP), revascularisation in addition to Best Medical Treatment (BMT), foot and wound care
•3. Have Aorto-Iliac (AI) ?inflow? adequate to support Vein Bypass (VB) and Best Endovascular Treatment (BET) (if not, then patients can be randomised after a successful AI procedure which can be either surgical or endovascular)
•4. Be judged suitable for both Vein Bypass and Best Endovascular Treatment following diagnostic imaging and a formal (documented) discussion by consultant vascular surgeon and interventional radiologist in a properly constituted multi-disciplinary team meeting

•Patients will be excluded if they:
•1. Have an anticipated life expectancy <6 months
•2. Are unable to provide consent due to incapacity (as defined by Mental Capacity Act 2005 or Adults with Incapacity [Scotland] Act 2000)
•3. Are a non-English speaker where translation facilities are insufficient to guarantee informed consent
•4. Are judged unsuitable for either of the two revascularisation strategies by the responsible consultant VS and IR

发起方

niversity of Birmingham (UK)