Sensome has announced enrollment of the first patients into a feasibility clinical study using the Clotild smart guidewire in peripheral arterial disease (PAD). Clotild was designated a breakthrough medical device for use in brain arteries by the 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 organized “old” clots. This critical information empowers physicians to select the most suitable endovascular therapeutic approach, thereby mitigating complications, avoiding embolization, 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, MD, head of the Department of Vascular Surgery at AZ Sint-Blasius Hospital and principal investigator of the SEPARATE clinical trial. “Sensome’s tissue microsensor technology could become a novel tool to characterize the total occlusion in an objective and simple-to-use way that integrates perfectly with our current existing workflow.”
