Clinical trial NCT04993079: Clotild® Smart Guidewire System (CSGS) Evaluation in EndovascUlar Thrombectomy Procedure
Official title: Clotild® Smart Guidewire System Evaluation in Endovascular Thrombectomy Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Sensome
Sponsor class: INDUSTRY
First posted: 2021-08-06
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: The proportion of patients having intracranial vessel perforation and / or dissection due to Clotild® usage at the site of usage in intracranial vessels
timeFrame: Measured during the procedure
measure: The ability to perform binary classification of individual electrophysiological parameter measurements
timeFrame: Measured during the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Southport
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Limoges
country: France
facility: CHU Limoges
Study officials:
affiliation: Liverpool Hospital, Liverpool NSW, Australia
name: Andrew Cheung, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Liverpool Hospital, Liverpool NSW, Australia
name: Dennis Cordato, MD
role: PRINCIPAL_INVESTIGATOR
References: