Eligibility

Local study conflicts

• None specific
• Co-enrollment is permitted but must be checked with the study team first
• Contact the research nurse team cuh.rdt@nhs.net or via secure chat to discuss

Inclusion Criteria:

• Adults (≥18 years) with symptomatic PAD (rest pain, tissue loss, or lifestyle-limiting claudication)
• Severe aorto-iliac occlusive disease (TASC II C/D)
• MDT consensus that both surgical and endovascular options are viable
• Ability to provide informed consent
• Ability to understand written English or availability of a translator to explain the trial documentation

Exclusion Criteria:

• Asymptomatic PAD
• Non-consent
• Comorbid conditions precluding intervention

Additional important information:

• Patient must be discussed at MDT to ensure equipoise prior to approaching patient

If the patient is eligible:

• Inform the patient that they may be eligible for a research study
• Gain verbal agreement in principle before proceeding. Explain:
• Taking part in research is likely to improve the quality of their care
• Risks are carefully controlled - research is safe
• Explain the uncertainty that exists with respect to treatment of their condition
• If they change their mind they can withdraw their participation at any point

Step-by-Step Guide to Recruitment:

In standard working hours

• The research nurse team is available from 08am-16pm Monday to Friday;
• In research team working hours contact the team via:
  • Secure Chat: Research Delivery Team EVOCC
  • Email: cuh.rdt@nhs.net

Eligibility confirmation

• Eligibility can only be confirmed by medical team on delegation log.
• Mr Tristan Lane, consultant vascular surgeon, is the PI and will know which members of staff who are delegated this role.
• Eligibility must be documented on EPIC using the smartphrase: .EVOCCELIGIBILITY.

Formal consent process

• Clinical team must have initial conversation with the patient and ask if details can be passed to the research nurse team
• Research nurse team to send out PIS and follow up to see if they are interested.
• Delegated medical team member to receive consent either face to face or over the telephone.
• Research nurses will ensure the doctor receiving consent has the correct version of the form.
• Doctor to complete smartphrases on EPIC: .EVOCCELIGIBILITY and .EVOCCANATOMY

Randomisation

• Research Nurse team will complete randomisation and inform clinical teams so appropriate theatre arrangements can be made.

Carrying out the procedure

• Any surgeon competent to complete the allocated procedure can operate as per standard of care.

When the ED Research team is not available:

• The study can only be recruited to within working hours

Follow up

• Follow up as per standard of care. Patients will need to be seen face to face at 6 months as standard of care. Blood results are required.

Links for further information:

Link to trial site