Sensome has announced enrolment of the first patients in the multicentre, first-in-human CLOT OUT study, which will evaluate the safety and performance of the company’s Clotild smart guidewire system in large-vessel acute ischaemic stroke patients. The first patients were enrolled at Gold Coast University Hospital (GCUH) in Gold Coast, Australia.
“Endovascular thrombectomy is no longer just about removing the clot,” said Hal Rice, director of Interventional Neuroradiology at GCUH (Gold Coast, Australia). “To get the best result for your patient, you need to get the clot out with complete revascularisation the first time. The Clotild guidewire is the first device that promises to provide live real-time information during the intervention that can help to increase our chances of choosing the right intervention approach from the get-go.”
Acute ischaemic stroke, a leading cause of long-term disability, can be treated by removing the clot blocking the brain blood vessel using mechanical thrombectomy devices, which are guided from the wrist or groin over a wire to the blockage. To improve patient prognosis, the clot needs to be removed as fast as possible.
Today though, without knowledge of the clot’s characteristics, the clot can only be removed on the first attempt in one out of three cases, according to a Sensome press release. The Clotild smart guidewire system integrates Sensome’s AI-powered tissue sensor and enables the guidewire to provide physicians with critical information on the clot.
“Evidence has been mounting over the past few years that factors like the biological clot composition should be considered when choosing the fastest method to remove a clot,” said Andrew Cheung, co-coordinating investigator of the study with Dennis Cordato—both of Liverpool Hospital in Liverpool, Australia. “The CLOT OUT trial aims to demonstrate that using Clotild in humans is safe and can detect clot composition.”
“After seven years of intense R&D [research and development], we are now starting a new chapter,” added Franz Bozsak, CEO and co-founder of Sensome. “We are very excited to work with an exceptional team of investigators to achieve our goal of making a difference for large-vessel acute ischaemic stroke patients.”
CLOT OUT is a multicentre, prospective trial intended to take place in leading stroke centres across Australia, Belgium, and France, and aims to enrol up to 100 patients. Data from the first cases will be presented this year at LINNC Paris 2021 (14–16 September, Paris, France and virtual) the Stroke Live Course Worldwide (SLICE 2021, 5–7 October, virtual).