Complex Endovascular Outcomes Study
Research type
Research Study
Full title
Novel endovascular technologies in complex lower limb revascularisation – cardiovascular outcomes in primary and secondary care in the UK
IRAS ID
356822
Contact name
Iain Roy
Contact email
Sponsor organisation
City St George's, University of London - St George’s School of Health and Medical Sciences
Clinicaltrials.gov Identifier
345375, IRAS Number ; 2024.0211, JRES reference number
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Peripheral arterial disease (PAD) is a condition that affects more than 200 million people worldwide. In PAD the arteries that carry blood into the legs become blocked or narrowed resulting in pain on walking, called intermittent claudication (IC) or pain at rest with/without wounds which is termed critical limb threatening ischaemia (CLTI). There are two main types of operation to try and improve the blood flow, an open surgical procedure or a minimally invasive procedure guided by x-rays called an endovascular procedure.
This project will investigate the outcomes of patients with PAD undergoing intervention. In recent years there has been significant advancements in the type of technology available for endovascular treatment. This project will explore whether the use of newer endovascular technologies reduces complications and improves survival in comparison to open or simple endovascular procedures. We will also investigate whether there is a relationship between the number of endovascular procedures performed (volume) and outcomes. Throughout the process we will study whether other factors impact outcome including but not limited to age, ethnicity, sex, geographical location, socioeconomic status and other medical diagnoses. We also plan to study the influence that the way GPs monitor factors (e.g. blood pressure, medications, and blood sugar control, all of which have been shown to affect patients with PAD) and patient outcomes.
To achieve these aims, this project will look at data that has been already routinely collected by the NHS. The data used is retrospective pseudonymised data collected by the NHS. The data sets being applied for are: hospital episode statistics (HES), HES:Civil Registrations of Death and Diagnostic Imaging Dataset (DID). By combining and analysing multiple datasets we will be able to fully investigate the association of new technology usage, GP management to determine if they are associated with better outcomes for CLTI.REC name
London - Surrey Research Ethics Committee
REC reference
25/LO/0360
Date of REC Opinion
8 May 2025
REC opinion
Favourable Opinion