Severe limb ischaemia due to femoro-popliteal disease Circulatory System Peripheral vascular disease, unspecified
Conditions
Interventions
Participants are randomly allocated to one of three treatment groups.
Group 1: Participants receive a plain balloon angioplasty with a bare metal stent (if needed)
Group 2: Participants receive a dr
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or over 2. Have severe limb ischaemia due to femoro-popliteal, with or without infra-popliteal, peripheral artery disease 3. Be judged by the responsible clinicians (consultant vascular surgeon, interventional radiologist, diabetologist) working as part of a multidisciplinary team to require early endovascular femoro-popliteal, with or without infra-popliteal revascularisation in addition to best medical treatment, foot and wound care 4. Have adequate ‘inflow’ to support all possible trial revascularisation strategies 5. Be judged suitable for all possible trial revascularisation strategies following diagnostic imaging and a formal (documented) discussion by a multi-disciplinary team meeting
Exclusion criteria
Exclusion criteria: 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 any of the revascularisation strategies being evaluated
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 |
|---|---|
| Not provided at time of registration | — |
Countries
England, United Kingdom
Contacts
Public ContactSuzanne Lockyer
Outcome results
None listed