Sensome’s Clotild Smart Guidewire Evaluated for PAD in SEPARATE Clinical Study

February 14, 2024—Sensome announced the enrollment of the first patients in the SEPARATE feasibility clinical study of the company’s Clotild smart guidewire for use in treating peripheral artery disease (PAD). The study will assess the Clotild sensor’s capability to detect various characteristics of blood vessel blockages in PAD patients.

According to the company, the Clotild smart guidewire system is a connected neurovascular guidewire designed to provide blood clot characterization during the endovascular management of acute ischemic stroke. The Clotild smart guidewire was previously designated a breakthrough medical device for use in brain arteries by the FDA in June 2021.

The first five patients have been enrolled in the SEPARATE trial at AZ Sint-Blasius Hospital in Dendermonde, Belgium. The clinical trial will evaluate the Clotild sensor’s capacity to differentiate between soft and friable “fresh” clots and organized “old” clots. The company noted that this information will help physicians select the most suitable endovascular therapeutic approach, thereby mitigating complications, avoiding embolization, and enhancing long-term treatment outcomes. Preliminary results are anticipated in mid-2024.

Koen Deloose, MD, head of Vascular Surgery at AZ Sint-Blasius Hospital, is Principal Investigator of the SEPARATE clinical trial.

“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,” stated Dr. Deloose in the press release. “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.”