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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04993079




Registration number
NCT04993079
Ethics application status
Date submitted
1/09/2020
Date registered
6/08/2021
Date last updated
24/05/2024

Titles & IDs
Public title
Clotild® Smart Guidewire System (CSGS) Evaluation in EndovascUlar Thrombectomy Procedure
Scientific title
Clotild® Smart Guidewire System Evaluation in Endovascular Thrombectomy Procedure
Secondary ID [1] 0 0
SEN_CLOTILD_FIH_1
Universal Trial Number (UTN)
Trial acronym
CLOTOUT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Clotild®

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 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.


Treatment: Devices: Clotild®
Use of Clotild® as neurovascular guidewire
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The proportion of patients having intracranial vessel perforation and / or dissection due to Clotild® usage at the site of usage in intracranial vessels
Timepoint [1] 0 0
Measured during the procedure
Primary outcome [2] 0 0
The ability to perform binary classification of individual electrophysiological parameter measurements
Timepoint [2] 0 0
Measured during the procedure

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/04/2024
Sample size
Target
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 0 0
NSW 2170 - Liverpool
Recruitment postcode(s) [2] 0 0
QL 5215 - Southport
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Limoges

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sensome
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04993079
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Cheung, MD
Address 0 0
Liverpool Hospital, Liverpool NSW, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04993079