Real World Testing of PreSize Neurovascular: medical device software to optimise stenting surgeries to reduce complications

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.