IRAS Project ID: 276573
Study Management Group
Chief investigator: Professor Roger Greenhalgh
Study Manager: tbc
Vascular Scientist: Mari Murumets
Advisory Study Manager: Pinar Ulug
Study summary
Rationale
There is a need to find an alternative Endovascular aneurysm repair (EVAR) surveillance protocol. Patients' adherence to the current follow-up protocol of annual CT or duplex ultrasound scans at hospital has been found to be poor. This has led to unacceptably high aneurysm-related mortality, and low cost-effectiveness of EVAR procedure.
Aims
The main aim of the study is to use a novel handheld ultrasound probe to measure outer wall to outer wall of the aortic sac after EVAR and compare this with the same measurement using duplex ultrasound scan, which is the current standard-of-care for post-EVAR surveillance. The study will determine if the sequential measurements taken by the novel probe would be reliable to assess increase in sac diameter as can be measured by the standard of care imaging.
The study also aims to find out in retrospect the relevant sac increase (mm/year) to precipitate referral for further imaging, detection of endoleak, and where necessary, rupture preventing reintervention.
It is predicted that, if the sac demonstrates any growth, then this indicates a leak in the aneurysm repair, and is predictive of future complications (e.g. rupture). These patients would require further attention from their clinician (such as further imaging and interventions). If the aortic sac does not show any growth, then the patient is of low-risk of complications. This subset of EVAR patients could be followed up more cost-effectively in the community, for example through ultrasound scans in primary care.
Design
The study will recruit patients who are male or female aged 50-85, who have undergone an elective endovascular aortic aneurysm repair (EVAR) for infrarenal aortic aneurysm. The study will recruit EVAR patients at any point in their annual follow up (i.e. from their first annual duplex at 12 months post-EVAR, onwards).
Funder
The Vascular Surgery Research Group at Imperial College London has been funded by the Camelia Botnar Arterial Research Foundation to run the study.
Contact
If you are a patient taking part in this study or a relative or carer of a study participant and you would like more information about the study please contact:
Study Co-ordinating Centre Staff at DETECT@imperial.ac.uk
We will be happy to discuss any concerns you have with the study or answer your questions.