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 sites345 target enrollmentMay 12, 2014

Overview

Registry

who.int

Start Date

May 12, 2014

End Date

April 30, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Birmingham (UK)

•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