Trial results for the Clotild® Smart Guidewire System in stroke patients were posted on ClinicalTrials.gov on 2026-01-23, reporting 0 intracranial vessel perforations or dissections.
Background
Stroke, particularly acute ischemic stroke, is a leading cause of disability and mortality worldwide. Endovascular thrombectomy (EVT) has become a standard of care for eligible patients, involving the mechanical removal of blood clots from cerebral arteries. The Clotild® Smart Guidewire System (CSGS) is designed to enhance EVT procedures by guiding the thrombectomy device to the clot and assessing clot characteristics in vivo, potentially improving procedural safety and efficacy.
Trial design
This completed First-in-Human study, designated as Phase NA, enrolled 45 participants with Stroke. The trial evaluated the safety of the Clotild® Smart Guidewire System (CSGS) when guiding endovascular thrombectomy devices to the clot location. A secondary objective was to assess the clinical performance and feasibility of measuring clot electrophysiological parameters in vivo during EVT procedures. The study was conducted as a single-arm evaluation.
Key results
The trial reported several key measurements related to safety and performance:
- The Proportion of Patients Having Intracranial Vessel Perforation and / or Dissection Due to Clotild® Usage at the Site of Usage in Intracranial Vessels in the Single Center group was 0 Participants.
- The Ability to Perform Binary Classification of Individual Electrophysiological Parameter Measurements by Distinguishing Local Regions With Substantial Versus Negligible RBC Content in the Occlusion was 0.97 (Probability (AUC of ROC curve)) with a 95% Confidence Interval.
- The Concordance Between Aggregated Occlusion Measurements (Clot-scale) Done by CSGS, and the Histology (i.e., Histopathology) Results of the Clot Retrieved During the EVT Procedure, Regarding Red Blood Cell Content in the Occlusion, was 0.19 (percentage per unit of percentage) with a 95% Confidence Interval.
- The Ability of CSGS to Detect the Proximal End of the Occlusion (Sensor-scale), as Compared to the Physician's Labelling (Tag 'PRE CLOT' for no Occlusion Contact and Tag 'CLOT' for Occlusion Contact), was 0.66 (Probability (AUC of ROC curve)) with a 95% Confidence Interval.
- Procedural Success Defined as the Ability to Navigate CSGS to the Occlusion Site and Measure Electrophysiological Properties of the Occlusion, was achieved in 26 Participants.
- The Ability to Perform Binary Classification of Individual Electrophysiological Parameter Measurements (Local-scale) by Distinguishing Local Regions With Substantial Platelet Content From Regions With Negligible Platelet Content in the Occlusion, was 0.94 (Probability (AUC of ROC curve)) with a 95% Confidence Interval.
- The Concordance Between Aggregated Occlusion Measurements (Clot-scale) Done by CSGS, and the Histology Results of the Clot Retrieved During the EVT Procedure, Regarding Platelet Content in the Occlusion, was -0.96 (percentage per unit of percentage) with a 95% Confidence Interval.
- The Ability to Perform Binary Classification of Individual Electrophysiological Parameter Measurements (Local-scale) by Distinguishing Local Regions With Substantial Fibrin Content From Regions With Negligible Fibrin Content in the Occlusion, was 0.41 (Probability (AUC of ROC curve)) with a 95% Confidence Interval.
- The Concordance Between Aggregated Occlusion Measurements (Clot-scale) Done by CSGS, and the Histology Results of the Clot Retrieved During the EVT Procedure, Regarding Fibrin Content in the Occlusion. was 0.11 (percentage per unit of percentage) with a 95% Confidence Interval.
What this means
The results of this first-in-human study suggest that the Clotild® Smart Guidewire System can be used safely in endovascular thrombectomy procedures for stroke, with no reported intracranial vessel perforations or dissections in the study population. The data also indicate the feasibility of using the system to measure electrophysiological parameters of occlusions, with varying abilities to classify and correlate with histological content for red blood cells, platelets, and fibrin. These findings support further investigation into how real-time clot characterization might optimize EVT strategies and improve patient outcomes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04993079, titled "Clotild® Smart Guidewire System (CSGS) Evaluation in EndovascUlar Thrombectomy Procedure", were posted on 2026-01-23 on clinicaltrials.gov.