N/A N=45 Other

Clotild® Smart Guidewire System (CSGS) Evaluation in EndovascUlar Thrombectomy Procedure

Stroke

Bottom Line

View on ClinicalTrials.gov: NCT04993079 ↗

Enrolled (actual)

Serious AEs

26.8%

Results posted

Jan 2026

Primary outcome: Primary: 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

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Clotild® Smart Guidewire System (CSGS) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Sensome
Primary completion: Apr 2024

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	—

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.

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

View full record on ClinicalTrials.gov →

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.