Sensome’s Clotild Smart Guidewire Evaluated for Identifying Fresh Clot in PAD

December 13, 2024—Sensome, a developer of microsensing technology for instant intra-operative tissue analysis, announced that results from two studies of its Clotild smart guidewire system demonstrated the device’s ability to identify “fresh” clot—thrombus rich in red blood cells (RBCs)—in peripheral artery disease (PAD) and differentiate it from other tissue encountered during PAD procedures.

Results from the SEPARATE and E-SEPARATE studies were presented in a late-breaking trial session at the Paris Vascular Insights Course 2024 held December 12-14 in Paris, France.

According to the company, the prospective, single-arm SEPARATE study was composed of 17 patients who were treated by Koen Deloose, MD, Head of the Department of Vascular Surgery at AZ Sint Blasius Hospital in Dendermonde, Belgium. In a postprocedure analysis, the study showed that there was a high level of agreement between the technology’s identification of fresh clot, the expert’s assessment of fresh clot, and the treatment decisions appropriate for fresh clot.

“Differentiating among tissues in an obstructed vessel in order to achieve successful peripheral revascularization is often limited by indistinct angiographic imaging, inaccurate patient medical history, and a lack of tactile guidewire feedback,” commented Dr. Deloose in the company’s press release. “The SEPARATE study shows us that Sensome’s clot-sensing technology could become a novel, real-time modality to reliably identify fresh clot at an expert level in interventional procedures, with the potential to improve vessel preparation and treatment decision-making for physicians of all experience levels treating PAD.”

The E-SEPARATE study was composed of 15 PAD patients who were scheduled for amputation or bypass at Groupe Hospitalier Paris Saint-Joseph in Paris, France.

According to Sensome, E-SEPARATE demonstrated the technology’s ability to differentiate fresh clot from other tissue collected from these PAD patients and examined ex vivo. It also demonstrated the correlation between the technology’s ability to determine the RBC content of clots collected from PAD patients with subacute and chronic lesions and a histological analysis of the same clot by an outside core lab, noted the company.

Professor Yann Gouëffic, MD, Professor of Vascular Surgery at Groupe Hospitalier Paris Saint-Joseph, discussed the results in Sensome’s press release.

“The E-SEPARATE study findings clearly demonstrate that symptom onset is an unreliable way to judge clot composition prior to treating a patient with PAD,” commented Prof. Gouëffic. “The clots retrieved from both chronic and subacute lesions contained both RBC-rich fresh clot and organized RBC-poor clots.”

Prof. Gouëffic continued, “In light of this, it’s important for us to know the clot type to decide how to treat these patients. Do we aspirate, dissolve the clot, or use another method? The Sensome technology has the potential to provide us with important information we are missing today to more effectively guide treatment and achieve better patient outcomes.”

As described in the company’s press release, the Clotild device is based on electrical impedance spectroscopy, which measures the electrophysiologic characteristics of fluid or tissue in the 360° surrounding the sensor, and analyzed by Sensome’s predictive models. Sensome has miniaturized the technology to fit on the distal part of a standard 0.014-inch guidewire, directly behind a soft, atraumatic tip.

The company stated that the technology can be integrated into devices commonly used during PAD procedures, such as guidewires and catheters, and has the potential to being able to objectively identify fresh clot during a procedure without changing current workflow.

The Clotild smart guidewire system has received FDA Breakthrough Device designation. It is an investigational device and is not approved for commercial use in the United States or any other market, advised Sensome.