Title: Real World Testing of PreSize Neurovascular: medical device software to optimise stenting surgeries to reduce complications
Funder: Department of Health and Social Care

Abstract: Research question: Develop evidence of efficacy and preliminary proof of effectiveness of PreSize Neurovascular software for planning brain stenting procedures. Background: Stents are popular and minimally invasive treatments for neurovascular diseases. These treatments carry risk of mortality, morbidity, and requirement for secondary treatment, partly because tools available to interventional neuroradiologists(INR) to plan these surgeries have severe shortcomings. PreSize Neurovascular is Class IM newly CE-marked software providing INR with visualisation and simulation capabilities. Developed by Oxford Heartbeat, the software accurately models stent deployment within blood vessels, allowing INRs to test different stents and placements virtually, until the optimal configuration is identified. Aims and Objectives: Collect real-world clinical trial data with which to assess preliminary efficacy and effectiveness of PreSize Neurovascular. Trial primary endpoint is clinically acceptable accuracy of software when used in real-world clinical situations. Eleven secondary endpoints collect data with which to populate health economics models and refine design of a future randomised control trial. Methods: Prospective observational clinical trial conducted at five NHS Trusts and led by St George s University Hospitals NHS Foundation Trust. 80 patients will be recruited. These patients will be treated with one of three stent makes. Data will be collected about the surgery planning and surgical procedure resulting from use of PreSize Neuovascular. Data about patients, including their 6 and 12-month clinical outcomes, will also be analysed. Timelines for delivery: 24-month project incorporating a 16-month clinical trial. Preparation for the trial lasts for five months; three months at the end is planned for data analyses and dissemination. Anticipated Impact and Dissemination: Project outputs include two publications in Journal of Neurointerventional Surgery, attendance at two major clinical conferences, health economics model and interactive budget-impact model. Project outputs expected to accelerate NHS market adoption, inform design of a future RCT, support MDR transition and NICE MTEP submission.

Lay abstract: Aim: This study tries to understand the benefits of computer software that can be used by doctors to help them plan for brain surgeries and how well it works in real world clinical practice, including how it can reduce waste of devices and lead to better patient outcomes. Background: Stents are small spring-like metallic devices used to strengthen weak blood vessels or open them up when they become clogged. This can prevent dangerous bleeding inside the body, saving lives. Each year fifty thousand stents are fitted in patients in the UK but no two procedures are the same. The shape and size of each blood vessel is different and stents made by different companies are also different. The success of the operation depends on the right &ldquo;fit&rdquo; of the stent in the diseased blood vessel. At the moment, doctors do not have good information to help them know which stent will give a good fit. If the fit is not good, the patient is still in danger and the doctors may try to do the surgery again. Oxford Heartbeat has built computer software called PreSize Neurovascular that can now be used by doctors to choose the best stent for each patient. Before buying the software, hospitals need confirmation that the software works well in real world and information, such as how much money might they save from using the software. This project will collect this information in a trial. Design and methods: Oxford Heartbeat will work with five hospitals to collect this information over two years. The doctors will plan certain brain operations with the software, to see how well it works, how much better the stent fit is and how much faster they can plan these operations with the help of the software. They will also collect information about the brain operations and about how the patients do up to 12 months after their operation. Oxford Heartbeat will compare this information with the same information collected for patients in the past to work out if the software helps to make the brain operations faster, if it means fewer stents are wasted, and if patients do better in the long run. They will then be able to work out how much money the hospitals saved because they used the software. Patient and public involvement: Oxford Heartbeat receives advice from a group of patients who had a stent operation in the past. These patients will help plan how the information will be collected at the hospitals, making sure the needs and rights of the patients whose information will be collected are respected and kept safe. Dissemination: The results from this study will be presented at important conferences and published in journals.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING;6.3 MEDICAL DEVICES
Health categories: CARDIOVASCULAR