Recruitment Complete for Landmark Clinical Impact Trial of PreSize® Neurovascular

London, 12th September 2024 – Oxford Heartbeat is thrilled to announce that the clinical impact trial of PreSize® Neurovascular, which featured on BBC Click last year, has successfully completed patient recruitment. 

This is a huge milestone as the trial - which is funded by the UK’s National Institute for Health and Care Research’s (NIHR) prestigious AI in Health and Care Award - is the first of its kind for decision-support software in the field. The trial sets a standard of evidence generation regarding the use of artificial intelligence software to support clinical decision making in neurovascular surgery and beyond. 

The registered and ethics-approved prospective, multi-centre trial is independently run by Imperial Clinical Trials Unit, with the aim of quantifying the benefits of using PreSize in clinical practice. In order to achieve this, 100 patients for whom PreSize was used to inform their treatment were recruited onto the trial. Overall, there was participation from 9 centres across the UK and a total of 25 surgeons. 

Patients included in the trial were diagnosed with a cerebral aneurysm and scheduled to be treated minimally invasively. This treatment involves placing a stent (flow diverter) into the affected blood vessel, to divert blood away from the aneurysm and minimise the risk of the aneurysm rupturing. However, choosing the best-fit device for each patient is challenging, and suboptimal choices resulting from current planning methods can lead to device wastage, surgical inefficiencies and patient complications. 

PreSize allows real-time virtual rehearsal of treatment scenarios, so the clinical team can determine the optimal device before starting the procedure. The software is CE-mark certified (compliant with safety/performance requirements for medical software) and has undergone rigorous testing; published studies have shown that it can be reliably used to inform clinical decisions with high levels of accuracy and can positively impact clinical decision making. 

The trial compares the clinical decision making between traditional methods (without PreSize) and with PreSize. When PreSize is used to support the selection of implants, information is collected on surgical efficiency metrics (such as devices used in the procedure and duration of surgery). It is the only such trial in the field, where data is prospectively collected to demonstrate objective and measurable benefits that the use of software can bring to patients and clinical teams in a real-world setting. 

Now that the study recruitment has been completed, the Imperial Clinical Trials Unit statistics team will analyse the dataset and the full results will be published in due course. Oxford Heartbeat are very excited to share the results of this groundbreaking study, and would like to thank the clinicians and clinical research teams involved in the trial for their commitment and interest in this landmark undertaking. A special thank you goes out to participants for agreeing to take part in the study, which will further our understanding of the impact of new technologies in patient care. With the collaborative work of researchers, clinicians, engineers and trial experts, we believe that this trial brings us one step closer to a future where safe and successful surgeries are the norm for every patient.

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