Introduction Mechanical thrombectomy has revolutionized the treatment of large-vessel ischemic stroke. In-situ thrombus features, such as thrombus composition, length and the resulting mechanical properties play a critical role in the success of endovascular treatment.

Aim of Study Sensome has developed the Clotild® Smart Guidewire System (CSGS), a 0.014’ neurovascular guidewire integrating an impedance micro-sensor in its distal part, allowing to probe the impedance properties of the occlusion causing the ischemic stroke during endovascular treatment. These properties can be analyzed using machine-learning algorithms with the aim to determine in-situ thrombus features. The CLOT OUT Study aims to evaluate the safety and ability of CSGS to provide impedance measurements.

Methods In this single arm, prospective, multi-center first-in-human study the Clotild® Smart Guidewire was used for impedance measurements before any thrombectomy pass in subjects presenting with AIS due to an occlusion with origin in the M1 and eligible for EVT. After EVT, the composition of retrieved thrombi was analyzed using Martius-Scarlett Blue and CD42b stains. Primary and secondary endpoints concern the safety of CSGS and the correlation of impedance measurements with expert and histological analysis. The study is controlled by an independent Data Safety Monitoring Board and supported by centralized histology and imaging core-labs.

Results Enrolment has been completed at 40 patients. There were no serious adverse events related to CSGS among the evaluated patients. A preliminary analysis demonstrates the feasibility to interpret the acquired impedance signals to determine in-situ thrombus features using predictive models.

Conclusion We will provide results from the final analysis at ESMINT 2024.

Disclosure of Interest yes Julie Lafaurie-Janvore, Joachim Rambeau, Franz Bozsak are employees of Sensome.