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

NCT ID: NCT04993079

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-26
• Study Completion Date: 2024-04-16

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Clotild®

Subjects presenting an acute ischemic stroke due to M1 or middle cerebral artery (MCA) bifurcation occlusion, eligible for Endovascular Thrombectomy (EVT) based on neuro-interventionist and/or neurologist investigators' opinion will be eligible. Twenty (20) patients will be initially enrolled. Up to 42 patients will be enrolled following an analysis of the data of the first 20 enrolled patients by a data safety monitoring board (DSMB) and its' recommendation to proceed with the study. Clots will be retrieved and analysed in a group of participants for which Clotild® is used as neurovascular guidewire.

Group Type: EXPERIMENTAL

Clotild® Smart Guidewire System (CSGS)

Intervention Type: DEVICE

Use of Clotild® Smart Guidewire System as neurovascular guidewire

Interventions

Clotild® Smart Guidewire System (CSGS)

Use of Clotild® Smart Guidewire System as neurovascular guidewire

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke eligible for EVT

2. M1 and/or MCA bifurcation arterial occlusion on Computed tomography angiography (CTA) or MRA (Magnetic resonance angiography) of an intracranial vessel amenable to EVT

3. 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

1. Patient having an intracranial occlusion other than M1 and/or MCA bifurcation, especially tandem occlusion and ICA (internal carotid artery) occlusion.

2. 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

3. Candidates not eligible for EVT based on neurointerventionist and/or neurologist investigators' opinion

4. Pregnancy or lactating subjects

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sensome

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Cheung, MD

Role: PRINCIPAL_INVESTIGATOR

Liverpool Hospital, Liverpool NSW, Australia

Dennis Cordato, MD

Role: PRINCIPAL_INVESTIGATOR

Liverpool Hospital, Liverpool NSW, Australia

Locations

Liverpool Hospital

Liverpool, New South Wales, Australia

Gold Coast University Hospital

Southport, Queensland, Australia

CHU Limoges

Limoges, , France

Countries

Australia; France

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SEN_CLOTILD_FIH_1

Identifier Type: -

Identifier Source: org_study_id