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

• Sponsor: Sensome (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04993079
• Collaborator: (none)
• Enrollment: 100
• Locations: 3
• Arm: 1
• Anticipated Duration (Months): 12.1
• Patients Per Site: 33.3
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Clotild®	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Clotild® Smart Guidewire System Evaluation in Endovascular Thrombectomy Procedure
• Actual Study Start Date: Aug 26, 2021
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Aug 30, 2022

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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 100 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. Sixty clots will be retrieved and analysed in a group of participants for which Clotild® is used as neurovascular guidewire.

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

Outcome Measures

Primary Outcome Measures

1. The proportion of patients having intracranial vessel perforation and / or dissection due to Clotild® usage at the site of usage in intracranial vessels [Measured during the procedure]

   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.

2. The ability to perform binary classification of individual electrophysiological parameter measurements [Measured during the procedure]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Liverpool Hospital	Liverpool	New South Wales	Australia	NSW 2170
2	Royal Brisbane and Women's Hospital	Herston	Queensland	Australia	QLD 4029
3	Gold Coast University Hospital	Southport	Queensland	Australia	QL 5215

Sponsors and Collaborators

• Sensome

Investigators

• Principal Investigator: Andrew Cheung, MD, Liverpool Hospital, Liverpool NSW, Australia
• Principal Investigator: Dennis Cordato, MD, Liverpool Hospital, Liverpool NSW, Australia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sensome
• ClinicalTrials.gov Identifier: NCT04993079
• Other Study ID Numbers: SEN_CLOTILD_FIH_1
• First Posted: Aug 6, 2021
• Last Update Posted: Apr 6, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 6, 2022