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

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ClinicalTrials.gov Identifier: NCT04993079
Recruitment Status : Recruiting
First Posted : August 6, 2021
Last Update Posted : April 6, 2022
Sponsor:
Information provided by (Responsible Party):
Sensome

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® Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 26, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : August 30, 2022

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




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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04993079


Contacts
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Contact: Hans Tielemans +33 1 85 37 07 70 hans@sensome.com
Contact: Franz Bozsak +33 1 85 37 07 70 franz@sensome.com

Locations
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Australia, New South Wales
Liverpool Hospital Recruiting
Liverpool, New South Wales, Australia, NSW 2170
Contact: Dennis Cordato         
Australia, Queensland
Royal Brisbane and Women's Hospital Not yet recruiting
Herston, Queensland, Australia, QLD 4029
Contact: Alan Coulthard         
Gold Coast University Hospital Recruiting
Southport, Queensland, Australia, QL 5215
Contact: Hal Rice         
Sponsors and Collaborators
Sensome
Investigators
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Principal Investigator: Andrew Cheung, MD Liverpool Hospital, Liverpool NSW, Australia
Principal Investigator: Dennis Cordato, MD Liverpool Hospital, Liverpool NSW, Australia
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Responsible Party: Sensome
ClinicalTrials.gov Identifier: NCT04993079    
Other Study ID Numbers: SEN_CLOTILD_FIH_1
First Posted: August 6, 2021    Key Record Dates
Last Update Posted: April 6, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No