Sensome has announced enrolment of the first patients into a feasibility clinical study using the Clotild smart guidewire in peripheral artery disease (PAD). Clotild was designated a breakthrough medical device for use in brain arteries by the US Food and Drug Administration (FDA) in 2021.
The clinical trial, named SEPARATE, is designed to assess the artificial intelligence (AI)-powered Clotild sensor’s capability to detect various characteristics of blood vessel blockages in PAD patients. The first five patients have been enrolled at AZ Sint-Blasius Hospital in Dendermonde, Belgium, and preliminary results are anticipated in mid-2024.
A key focus of the SEPARATE clinical trial—according to a Sensome press release—is to evaluate the Clotild sensor’s capacity in differentiating between soft and friable “fresh” clots, and organised “old” clots. This critical information empowers physicians to select the most suitable endovascular therapeutic approach, thereby mitigating complications, avoiding embolisation, and enhancing long-term treatment outcomes, the release adds.
“Understanding the makeup of a total occlusion in peripheral artery disease is essential to choose an adequate treatment approach to ensure lower complication rates and more durable long-term outcomes in this complex group of vascular patients,” said Koen Deloose (AZ Sint-Blasius Hospital, Dendermonde, Belgium), principal investigator of the SEPARATE clinical trial. “Sensome’s tissue microsensor technology could become a novel tool to characterise the total occlusion in an objective and simple-to-use way that integrates perfectly with our current existing workflow.”
Franz Bozsak, chief executive officer and co-founder of Sensome, added: “After successfully applying our technology to the treatment of ischaemic stroke patients, we are excited about the opportunity to build on this work to potentially help millions of patients around the world whose lives have been impacted by PAD.”
