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

Stroke Clinical Trial

— CLOTOUT  

Official title:

Clotild® Smart Guidewire System Evaluation in Endovascular Thrombectomy Procedure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04993079
• Other study ID #: SEN_CLOTILD_FIH_1
• Status: Completed
• Phase: N/A
• Start date: August 26, 2021
• Est. completion date: April 13, 2024

Study information

• Verified date: August 2023
• Source: Sensome
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 13, 2024
• Est. primary completion date: April 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Clotild®
Use of Clotild® as neurovascular guidewire

Locations

Country	Name	City	State
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Gold Coast University Hospital	Southport	Queensland
France	CHU Limoges	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
Sensome

Countries where clinical trial is conducted

Australia,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients having intracranial vessel perforation and / or dissection due to Clotild® usage at the site of usage in intracranial vessels	Tthe proportion of patients having intracranial vessel perforation and / or dissection due to Clotild® usage at the site of usage in intracranial vessels will be assessed by Interventional Neuroradiologist during the procedure and final adjudication of the DSA (Digital Subtraction Angiography) by the Data Safety Monitoring Board.	Measured during the procedure
Primary	The ability to perform binary classification of individual electrophysiological parameter measurements	The ability to perform binary classification of individual electrophysiological parameter measurements will be assessed by distinguishing local regions with substantial red blood cell content (RBC-rich) from regions with negligible red blood cell content (RBC-poor) in the occlusion.	Measured during the procedure