In Human Feasibility Trials and Usability Development for 1View – Augmented reality software and platform for inter-operative guidance during Mechanical Thrombectomy (MT) procedures - Giving Stroke victims a better chance

Research Question Can the development of novel software technology improve the outcomes for patients undergoing mechanical thrombectomy for the treatment of acute ischaemic stroke? Background Stroke is a leading cause of death and disability worldwide. Mechanical thrombectomy is an effective treatment method for acute ischaemic stroke caused by a large vessel occlusion. However, this procedure is associated with high rates of complications and suboptimal outcomes. Technological advances in the field of software for medical imaging processing, preoperative planning and intraoperative guidance, may provide a solution to these challenges. Aims and Objectives The aim of this research is to develop and evaluate software tools that can enhance the effectiveness and safety of mechanical thrombectomy for the treatment of stroke. The specific objectives are to: Develop real-time 3D image analysis and segmentation techniques capable of accurately identifying the location and extent of the occlusion, the collateral circulation, and key vascular waypoints beforehand; Develop a tool to simulate multiple fluoroscopic projections preoperatively, such that time can be saved by choosing optimal viewing angles prior to the procedure; Develop robust and accurate tracking methods to identify guidewires and other instrumentation in 2D fluoroscopic images; Develop intuitive user interfaces for both traditional 2D display technology and AR headset platforms, in response to bench testing and user feedback; Demonstrate that the platform can be integrated seamlessly with existing hospital IT infrastructure; Prepare the necessary documentation for UKCA regulatory approval; and Evaluate the feasibility, safety and effectiveness of these tools in a clinical trial. Methods This research will involve a multidisciplinary team of experts in stroke, radiology, computer science and numerical mathematical methods. The software tools will be developed using state-of-the-art technologies, such as machine learning and holographic visualisation through AR headset displays. The research will incorporate a prospective clinical trial, which will be conducted at one of the leading stroke centres in the UK, and will include patients who are eligible for mechanical thrombectomy. The key outcomes of interest will include the rate of successful reperfusion, the rate of complications, the time taken to undertake each stage of the procedure, and measures of postoperative functional ability. Timelines for Delivery The software tools will be developed over a period spanning nearly two years, encompassing regular testing and validation. The clinical trial will commence thereafter once the software tools are deemed safe and effective. Anticipated Impact and Dissemination The anticipated impact of this research is to demonstrate that the clinical outcomes of patients undergoing mechanical thrombectomy for the treatment of stroke can be improved, such that the software platform facilitating this change can be deployed across all eligible stroke treatment centres to maximise impact. The dissemination of this work will occur through a variety of channels, including scientific publications in high-impact journals, national and international conferences, and patient-focused stroke groups and associations. The ultimate goal is to improve the quality of care for stroke patients and reduce the burden of this devastating disease on individuals and society.