Revascularisation for common femoral artery steno-occlusive disease Circulatory System
Conditions
Interventions
Randomisation is 1:1 and performed through a web-based service called Sealed Envelope. Participants are randomised to undergo either open surgery or endovascular treatment.
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Age >=18 years 2. Chronic limb-threatening ischemia (CLTI) (rest pain and/or tissue loss) or severe lifestyle-limiting claudication (Rutherford Stage >=3 or Fontaine Stage >=IIb) 3. Patient deemed suitable for common femoral artery (CFA) open surgery or endovascular treatment by the treating clinicians (pragmatic design) For participants with bilateral disease, the leg with more severe symptoms will be designated as the trial leg, as per other RCTs. Adjunctive inflow/outflow procedures will be permitted, with decisions regarding these left to the discretion of operators (pragmatic design).
Exclusion criteria
Exclusion criteria: 1. Asymptomatic peripheral artery disease (PAD) 2. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of death (all-cause) and/or reintervention (major amputation or lower limb revascularisation) is measured over a minimum of 1 year (time-to-event analysis). Major amputation is defined as any amputation above the level of the ankle joint in the ipsilateral lower limb. Revascularisation is defined as any arterial revascularisation in the ipsilateral lower limb. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life measured using the EuroQOL-5D (EQ-5D-5L) score at baseline and months 6, 12, 24 and 36 2. Mortality (all causes), measured using information from medical records and local trust systems, causes of death and death certificate information will be collected within study CRFs by the local research team. Main timepoints: day of discharge, 30 days post, 6, 12, 24, 36 months and final assessment. 3. Hospital admissions (including reason for admission), reinterventions (including nature of reintervention) and all lower limb amputations (minor and major, i.e., below and above the ankle joint), measured using information from medical records and local trust systems, including procedural details. This can be a separate event at 6, 12, 24 and 36 months (or final assessment) for those that don’t complete full follow-up by the end of the trial. 4. Healthcare resource-use and costs (participant medical notes). Review of medical notes will be used to ensure capture of postoperative appointments in primary/community care. Further, telephone remote follow-up (centrally) will be used to capture missing information regarding amputations, reinterventions, readmissions, and mortality (relating to the primary outcome). Resource use is measured at 6, 12, 24 and 36 months; costs will be pulled from procedural information which could be a separate event (re-intervention) but is captured at the follow-up points listed above unless the research team is made aware between follow-up points an event (admission/re-intervention/death) may occur. | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactAthanasios;Luke Saratzis;Ingram
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Outcome results
None listed