NCT04993079

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

Clotild® Smart Guidewire System Evaluation in Endovascular Thrombectomy Procedure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Sensome · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Clotild® is a neurovascular guidewire equipped with the Sensome proprietary impedance sensor. The latter allows the measurement of the electrophysiological characteristics of the surrounding tissues. Clotild® could categorize the thrombus occluding the cerebral blood vessel, and support the neurointerventionist during mechanical thrombectomy for the treatment of ischemic stroke. The aim of the study is to evaluate the safety and the performance of the device. The electrophysiological measurements will be used to update Clotild®'s database and thus improve the prediction accuracy of the model in providing physicians with insights for mechanical thrombectomy.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Clotild® Smart Guidewire System (CSGS)	Use of Clotild® Smart Guidewire System as neurovascular guidewire

Timeline

• Start date: 2021-08-26
• Primary completion: 2024-04-13
• Completion: 2024-04-16
• First posted: 2021-08-06
• Last updated: 2026-02-27
• Results posted: 2026-01-23

Locations

3 sites across 2 countries: Australia, France