Sensome today announced positive results from two studies of its Clotild smart guidewire system demonstrating its ability to successfully identify fresh clot—thrombus rich in red blood cells (RBCs)—in peripheral arterial disease (PAD) and differentiate it from other tissue encountered during PAD procedures. Results from the SEPARATE and E-SEPARATE studies were presented at the Paris Vascular Insights (PVI) course 2024 (12–14 December, Paris, France).
A press release details that the Clotild clot-sensing guidewire integrates the world’s smallest electrical impedance sensor with machine learning. For PAD, the clot-sensing technology is being developed to instantly identify fresh clot and differentiate it from organised clot as well as plaque, calcium and other tissue in real-time in order to inform individualised PAD treatment. Sensome notes that the technology can be integrated into devices commonly used during PAD procedures, such as guidewires and catheters, and has the potential to enable the first device capable of objectively identifying fresh clot during a procedure without changing current workflow.
The prospective, single-arm SEPARATE study encompassed 17 patients treated by Koen Deloose (AZ Sint Blasius Hospital, Dendermonde, Belgium). The study showed in a post-procedure analysis 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 revascularisation is often limited by indistinct angiographic imaging, inaccurate patient medical history and a lack of tactile guidewire feedback. 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,” said Deloose.
A second study of the Sensome technology—E-SEPARATE—was conducted with 15 PAD patients (scheduled for amputation or bypass) at a single centre in France and had two interesting findings, according to a press release. The study showed the technology’s ability to differentiate fresh clot from other tissue collected from these PAD patients and examined ex vivo. It also demonstrated an excellent 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.
“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. The clots retrieved from both chronic and subacute lesions contained both RBC-rich fresh clot and organised RBC-poor clots. 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,” said Yann Gouëffic (Groupe Hospitalier Paris Saint-Joseph, Paris, France).
In two previous peer-reviewed publications, the company’s microsensor technology was shown to reliably predict the composition of RBCs in retrieved clot with good sensitivity and specificity consistent with histologic findings.
