N/A
Completed N=45
Clotild® Smart Guidewire System (CSGS) Evaluation in EndovascUlar Thrombectomy Procedure
Source: ClinicalTrials.gov NCT04993079 ↗Enrolled (actual)
45
Serious AEs
26.8%
Results posted
Jan 2026
Primary outcomePrimary: The Proportion of Patients Having Intracranial Vessel Perforation and / or Dissection Due to Clotild® Usage at the Site of Usage in Intracranial Vessels — 0 Participants
Summary
The purpose of this First-in-Human study is to evaluate the safety of using the Clotild® system to guide the endovascular thrombectomy (EVT) device to the clot location during EVT for the treatment of an acute ischemic stroke eligible to EVT, whatever the EVT device chosen. A secondary purpose is to assess the clinical performance, defined as the feasibility of measuring clot electrophysiological parameters in vivo during EVT procedures.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Proportion of Patients Having Intracranial Vessel Perforation and / or Dissection Due to Clotild® Usage at the Site of Usage in Intracranial Vessels |
— | — |
| PRIMARY The Ability to Perform Binary Classification of Individual Electrophysiological Parameter Measurements by Distinguishing Local Regions With Substantial Versus Negligible RBC Content in the Occlusion |
0.97 | — |
| SECONDARY 1. 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, |
0.19 | — |
| SECONDARY 2. 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), |
0.66 | — |
| SECONDARY 3. Procedural Success Defined as the Ability to Navigate CSGS to the Occlusion Site and Measure Electrophysiological Properties of the Occlusion, |
26 | — |
| SECONDARY 4. 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, |
0.94 | — |
| SECONDARY 5. 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, |
-0.96 | — |
| SECONDARY 6. 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, |
0.41 | — |
| SECONDARY 7. 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. |
0.11 | — |
Eligibility Criteria
Inclusion Criteria
- Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke eligible for EVT
- M1 and/or MCA bifurcation arterial occlusion on Computed tomography angiography (CTA) or MRA (Magnetic resonance angiography) of an intracranial vessel amenable to EVT
- Informed Consent by subject, subject's Legally Authorized Representative (LAR) or anyone approved by the Ethics Committee (EC) and/or regulatory agencies to provide consent on behalf of the subject.
Exclusion Criteria
- Patient having an intracranial occlusion other than M1 and/or MCA bifurcation, especially tandem occlusion and ICA (internal carotid artery) occlusion.
- Current participation in another investigational device or drug study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
- Candidates not eligible for EVT based on neurointerventionist and/or neurologist investigators' opinion
- Pregnancy or lactating subjects
Data sourced from ClinicalTrials.gov (NCT04993079). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.