Severe ischaemia of the lower limb due to infrageniculate arterial disease Circulatory System
Conditions
Interventions
The interventions are either vein bypass surgery or best endovascular treatment. Best endovascular treatment will involve balloon angioplasty and possibly the use of stents. Randomisation will be on a
Sponsors
University of Birmingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amputation Free Survival (AFS), defined as the time to major limb (above the ankle) amputation of the index (trial) limb or death from any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall Survival (OS) 2. In-hospital and 30-day morbidity and mortality 3. Major Adverse Limb Event, defined as amputation (transtibial or above) or any major vascular re-intervention (thrombectomy, thrombolysis, balloon angioplasty, stenting, or surgery) 4. Major cardiovascular events (SLI and amputation affecting the contralateral limb, acute coronary syndrome, stroke) 5. Relief of ischaemic pain [visual analogue scale (VAS), medication usage] 6. Psychological morbidity [Hospital Anxiety and Depression Scale (HADS)] 7. Quality of life (QoL) using generic [EQ-5D-5L, SF-12, ICEpop CAPability measure for Older people (ICECAP-O)] and disease-specific (VascuQoL) tools 8. Re- and cross-over intervention rates 9. Healing of tissue loss (ulcers, gangrene) as assessed by the PEDIS and the WiFi scoring and classification systems 10. Extent and healing of minor (toe and forefoot) amputations (also using PEDIS and WiFi) 11. Haemodynamic changes; absolute ankle and toe pressures, ankle brachial pressure index (ABPI), toe brachial pressure index (TBPI) | — |
Countries
England, United Kingdom
Contacts
Public ContactSuzanne Lockyer
Outcome results
None listed