## Protocol Section
### Identification Module
**NCT ID:** NCT04993079

**Acronym:** CLOTOUT

**Brief Title:** Clotild® Smart Guidewire System (CSGS) Evaluation in EndovascUlar Thrombectomy Procedure

**Official Title:** Clotild® Smart Guidewire System Evaluation in Endovascular Thrombectomy Procedure

#### Organization Study ID Info
**ID:** SEN_CLOTILD_FIH_1
#### Organization
**Class:** INDUSTRY
**Full Name:** Sensome
### Status Module
#### Completion Date
**Date:** 2024-04-13

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2024-04-13

**Type:** ACTUAL

#### Start Date
**Date:** 2021-08-26

**Type:** ACTUAL

**Status Verified Date:** 2023-08

#### Study First Post Date
**Date:** 2021-08-06
**Type:** ACTUAL
**Study First Submit Date:** 2020-09-01
**Study First Submit QC Date:** 2021-08-05
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Sensome

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Stroke

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 41

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Device: Clotild®

**Label:** Clotild®

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Clotild®

**Description:** Use of Clotild® as neurovascular guidewire

**Name:** Clotild®

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** 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

**Description:** 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.

**Measure:** The ability to perform binary classification of individual electrophysiological parameter measurements

**Time Frame:** Measured during the procedure

### Eligibility Module

**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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Liverpool

**Country:** Australia

**Facility:** Liverpool Hospital

**State:** New South Wales

**Zip:** NSW 2170

**Location 2:**

**City:** Southport

**Country:** Australia

**Facility:** Gold Coast University Hospital

**State:** Queensland

**Zip:** QL 5215

**Location 3:**

**City:** Limoges

**Country:** France

**Facility:** CHU Limoges

**Zip:** 87000

#### Overall Officials

**Official 1:**

**Affiliation:** Liverpool Hospital, Liverpool NSW, Australia

**Name:** Andrew Cheung, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Liverpool Hospital, Liverpool NSW, Australia

**Name:** Dennis Cordato, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M22306

- Name: Stroke

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
