Sensome Announces Data from Two Studies of Clot-Sensing Guidewire in Peripheral Artery Disease Treatment

Sensome announced positive results from two studies of its Clotild Smart Guidewire System demonstrating its ability to identify thrombus rich in red blood cells (RBCs) in peripheral artery disease (PAD) and differentiate it from other tissue encountered during PAD procedures. 

The Clotild clot-sensing guidewire integrates the world’s smallest electrical impedance sensor with machine learning. The clot-sensing technology is being developed to identify “fresh” clots and differentiate them from organized clots, as well as plaque, calcium, and other tissue, to inform individualized PAD treatment. 

The technology can be integrated into devices commonly used during PAD procedures, such as guidewires and catheters. It has the potential to enable the first device capable of objectively identifying “fresh” clots during a procedure without changing current workflows.

“The ability of our technology to accurately identify ‘fresh’ clot is an exciting achievement in the evolution of PAD treatment that we expect will improve operator success and patient experience,” said Sensome CEO Franz Bozsak. “We have now seen positive outcomes from our initial clinical work in PAD and ischemic stroke and anticipate similarly positive findings from our current study in lung cancer. We are enthusiastic about the potential of our real-time, intra-operative tissue analysis technology to enhance the efficacy of a variety of minimally invasive procedures that are currently limited by existing imaging modalities.”

SEPARATE was a prospective, single-arm study that included 17 patients treated by Koen Deloose, MD, Head of the Department of Vascular Surgery at AZ Sint Blasius Hospital, Belgium. 

The study showed in a post-procedure analysis that there was a high level of agreement between the technology’s identification of “fresh” clots, the expert’s assessment of “fresh” clots, and the treatment decisions appropriate for “fresh” clots. 

E-SEPARATE, Sansome’s second study, was conducted with 15 PAD patients (scheduled for amputation or bypass) at Groupe Hospitalier Paris Saint-Joseph in France. 

The E-SEPARATE study showed the technology’s ability to differentiate “fresh” clots from other tissue collected from these PAD patients and examined ex-vivo. It also demonstrated a correlation between the technology’s ability to determine the RBC content of clots collected from PAD patients with sub-acute and chronic lesions and a histological analysis of the same clot by an outside core lab.

Results from the SEPARATE and E-SEPARATE studies were presented in a late-breaking trial session at the Paris Vascular Insights Course.

In two previous peer-reviewed publications, the company’s microsensor technology was shown to predict the composition of red blood cells (RBC) in retrieved clots with good sensitivity and specificity consistent with histologic findings.^1,2

References:

¹ Darcourt J, Brinjikji W, François O, et al. Identifying ex vivo acute ischemic stroke thrombus composition using electrochemical impedance spectroscopy. Interventional Neuroradiology. 2023;0(0). doi:10.1177/15910199231175377.

² Sahin C, Giraud A, Jabrah D, et al. Electrical impedance measurements can identify red blood cell-rich content in acute ischemic stroke clots ex-vivo associated with first pass successful recanalization. Res Pract Thromb Haemost. 2024;8:e102373. DOI:https://doi.org/10.1016/j.rpth.2024.102373.