First-in-human stroke trial reads blood clots from the inside
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Scientists at the University of Galway have taken part in a first-in-human study of stroke patients using a thin wire fitted with sensors to assess and map their clots.
The study involved the use of a guidewire called Clotild, which has been developed by medtech company Sensome. It can navigate arteries through a catheter, with tiny electrical sensors built into its tip, moving through a clot and continuously measuring how well different tissues conduct a small current. Red blood cells, platelets and arterial walls each have distinct electrical "fingerprints" that can be individually identified in real time by the device's prediction model.
Some 41 people who had suffered a large-vessel occlusion stroke were enrolled in the trial at hospitals in Australia and France to assess the device's performance and how it reports the clot.
The trial was led by Dr. Andrew Cheung of Liverpool Hospital, NSW, Australia, and Aymeric Rouchaud, France, using a device developed with clot analysis by Professor Karen Doyle of the University of Galway and Rinn Medical Devices Centre. The research is published in the Journal of NeuroInterventional Surgery.
Professor Doyle said, "This first-in-human study represents an important step forward in how we understand and treat stroke patients. Being able to characterize clot composition in real time, during the procedure itself, has real potential to help clinicians tailor their approach to treating each patient and improve outcomes. It's been a privilege to contribute to the research underpinning this trial and to see fundamental device research translated into a technology now being tested directly in patients."
Every year, millions of people globally suffer a stroke caused by a blood clot blocking an artery in the brain. The gold-standard treatment is a procedure called mechanical thrombectomy, in which a tiny device is threaded through blood vessels to physically pull the clot out. Research has shown that removing a clot in a single pass dramatically improves a patient's chances of recovery. While this method can be successful, surgeons go in almost blind, knowing very little about the clot they are about to tackle, what it is made of or where exactly it ends.
The trial is the first time a potential solution to this issue has been tested in humans.
The possibility of removing a clot in one pass depends partly on clot composition: Clots rich in red blood cells behave differently from those packed with platelets. Until now, the only way to find this out was to analyze retrieved clot fragments under a microscope following a procedure—too late to change the surgical strategy.
The results from the trial were unambiguous: Not a single patient experienced a vessel perforation or dissection, the most feared complication of guidewire use in the brain.
On performance, Clotild proved remarkably accurate. Its ability to distinguish red blood cell-rich clots from platelet-rich ones scored 0.97 and 0.94, respectively, on a standard accuracy scale where 1.0 is perfect.
The device was also able to detect the artery wall and the far end of the clot, information a surgeon could use to gauge clot length without injecting contrast dye.
One of the most striking demonstrations came when the team reconstructed a full compositional "map" of a clot based on Clotild's continuous readings as it passed through. The map, showing which sections were red blood cell-rich and which were not, matched what histology later revealed about the retrieved clot fragments.
Cheung said, "This trial shows that impedance-based clot characterization is not only feasible but can be integrated safely into standard procedure. It's the result of a genuinely international effort, and I want to thank our collaborators across Australia, France, the U.S. and Ireland for their contribution to the device development and data analysis that made these results possible."
Dr. Franz Bozsak, CEO of Sensome, said, "Bringing Clotild from concept to first-in-human trial has depended on close collaboration between industry and academic research partners. The expertise contributed by our academic partners across the globe has been invaluable in helping us validate and refine the science behind this technology. This kind of partnership is exactly how we believe medical devices should be developed, grounded in rigorous academic research and tested rapidly in clinical settings."
Doyle added, "As a proof of concept, this is compelling. The vision is a future where, before a surgeon even selects a retrieval device, they already know exactly what kind of clot they are dealing with, giving stroke patients a meaningfully better chance of getting it out the first time."
Publication details
Andrew Cheung et al, In situ impedance analysis device for clot characterization in large vessel occlusion acute ischemic stroke, a first-in-human study, Journal of NeuroInterventional Surgery (2026). DOI: 10.1136/jnis-2025-024772
Journal information: Journal of NeuroInterventional Surgery
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