StrokeCLOTOUTNCT04993079
Clotild® Smart Guidewire System (CSGS) Evaluation in EndovascUlar Thrombectomy Procedure
A study testing Clotild® Smart Guidewire System (CSGS) in people with Stroke, run by Sensome at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Clotild® Smart Guidewire System (CSGS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 26 Aug 2021to 16 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke eligible for EVT
- M1 and/or MCA bifurcation arterial occlusion on Computed tomography angiography (CTA) or MRA (Magnetic resonance angiography) of an intracranial vessel amenable to EVT
- 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.
Who cannot join
- Patient having an intracranial occlusion other than M1 and/or MCA bifurcation, especially tandem occlusion and ICA (internal carotid artery) occlusion.
- 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
- Candidates not eligible for EVT based on neurointerventionist and/or neurologist investigators' opinion
- Pregnancy or lactating subjects
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Australia2 sites
Liverpool Hospital
Liverpool, New South Wales, NSW 2170
Gold Coast University Hospital
Southport, Queensland, QL 5215
About this study
Official title: Clotild® Smart Guidewire System Evaluation in Endovascular Thrombectomy Procedure
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.
Read the 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
- Stroke
- Being tested
- Clotild® Smart Guidewire System (CSGS)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clotild® Smart Guidewire System (CSGS)Device
Use of Clotild® Smart Guidewire System as neurovascular guidewire
| Study group | Role | What they receive |
|---|---|---|
| Clotild® | Experimental | 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. Receives: Device: Clotild® Smart Guidewire System (CSGS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Proportion of Patients Having Intracranial Vessel Perforation and / or Dissection Due to Clotild® Usage at the Site of Usage in Intracranial Vessels
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.
Measured: Measured during the procedure and up to 24hr follow-up (when the 24hr images are taken)
The Ability to Perform Binary Classification of Individual Electrophysiological Parameter Measurements by Distinguishing Local Regions With Substantial Versus Negligible RBC Content in the Occlusion
- The performance of the CSGS model will be assessed by the performance metric Area Under the Receiver Operator Characteristic curve (AUC of ROC) computed from the RBC-content score predicted on the validation dataset only.
- The ROC curve will be defined by the sensitivity (true positive rate) on the Y-axis and 1- specificity (false positive rate) on the X-axis. The ground truth is defined as the binary classification of the local regions into RBC-positive or RBC-negative content performed by SENSOME experts.
- The comparator will be the binary classification score determined by the CSGS model. The CSGS model will be developed using interventions from the development phase (Development Performance Population) while it will be validated on the impedance data from the validation phase (Local-Scale Performance Population).
Measured: Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject)
Secondary outcomes (7)
1. The Concordance Between Aggregated Occlusion Measurements (Clot-scale) Done by CSGS, and the Histology (i.e., Histopathology) Results of the Clot Retrieved During the EVT Procedure, Regarding Red Blood Cell Content in the Occlusion,
This endpoint evaluated the clot-scale predicted RBC% as compared to histological evaluation of RBC%.
The analyzed dataset comprised the interventions from the clot-scale validation performance population for which at least one tagged measurement was predicted with clot contact.
The concordance is to be evaluated by the slope of the linear regression of the independent variable "RBC percentage predicted at clot scale" against the dependent variable "RBC percentage measured by histology".
No additional factors or covariates were included when assessing the linear regression.
Measured: Occlusion Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject). Clot retrieved few minutes after study procedure ended.
2. The Ability of CSGS to Detect the Proximal End of the Occlusion (Sensor-scale), as Compared to the Physician's Labelling (Tag 'PRE CLOT' for no Occlusion Contact and Tag 'CLOT' for Occlusion Contact),
This endpoint sought to evaluate the ability of study device (CSGS) to detect the proximal end of the occlusion, as compared to the physician's labelling. The concordance was judged by the Area Under the Curve of Receiver Operating Characteristic (AUC of ROC) on the validation dataset. Evaluation included those interventions from the validation set where the 'PRE CLOT' and 'CLOT' tagged measurements were acquired with at most one missing or anomalous individual measurement
Measured: Measurements taken by the investigator during the first few minutes of the study procedure
3. Procedural Success Defined as the Ability to Navigate CSGS to the Occlusion Site and Measure Electrophysiological Properties of the Occlusion,
Procedural success defined as the ability to navigate the investigational device to the occlusion and measure electrophysiological properties of the occlusion. Procedural success was achieved from the moment that at least one evaluable measurement in the occlusion was captured by the investigational device.
Measured: Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject
4. The Ability to Perform Binary Classification of Individual Electrophysiological Parameter Measurements (Local-scale) by Distinguishing Local Regions With Substantial Platelet Content From Regions With Negligible Platelet Content in the Occlusion,
The ability to perform binary classification was evaluated by the performance metric AUC of ROC (Area under the Curve of Receiver Operating Characteristic) computed from the platelet-content score predicted on the validation dataset. The same methodology was used as for the primary performance endpoint.
Measured: Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject
5. The Concordance Between Aggregated Occlusion Measurements (Clot-scale) Done by CSGS, and the Histology Results of the Clot Retrieved During the EVT Procedure, Regarding Platelet Content in the Occlusion,
This endpoint evaluated the clot-scale predicted platelet content as compared to histological evaluation (CD42b immunostaining). The analysis was performed using the clot-scale validation performance population.
- To determine the histological results of the clot, the platelet % composition (value between 0 and 100) was averaged over the 3 analyzed slides provided by the Core Laboratory.
- Significant correlation was judged at the 0.05 significance level by the t-statistic of the linear coefficient of the ordinary linear regression between the independent variable "platelet % content as output by the prediction model" and the dependent variable "platelet % content as quantified by the IHC CD42b immunochemistry staining histological analysis". A complimentary analysis was carried out considering the MSB 'Platelets and other' percentage quantification provided by the histology core lab.
No additional factors or covariates were included when assessing the linear regression
Measured: Occlusion Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject). Clot retrieved few minutes after study procedure ended.
6. The Ability to Perform Binary Classification of Individual Electrophysiological Parameter Measurements (Local-scale) by Distinguishing Local Regions With Substantial Fibrin Content From Regions With Negligible Fibrin Content in the Occlusion,
The ability to perform binary classification was evaluated by the performance metric AUC of ROC (Area Under the Curve of Receiver Operating Characteristic) computed from the platelet-content score predicted on the validation dataset. The same methodology was used as for the primary performance endpoint.
Measured: Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject)
7. The Concordance Between Aggregated Occlusion Measurements (Clot-scale) Done by CSGS, and the Histology Results of the Clot Retrieved During the EVT Procedure, Regarding Fibrin Content in the Occlusion.
This endpoint evaluated the clot-scale predicted fibrin content as compared to histological evaluation (MSB staining), using the clot-scale validation performance population.
- To determine the histological results of the clot, the fibrin percentage composition (value between 0 and 100) was averaged over the 3 analyzed slides provided by the core lab.
- Significant correlation was judged at the 0.05 significance level by the t-statistic of the linear coefficient of the ordinary linear regression between the independent variable "fibrin percentage content as output by the prediction model" and the dependent variable "fibrin percentage content as quantified by the MSB-staining histological analysis".
No additional factors or covariates were included when assessing the linear regression.
Measured: Occlusion Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject). Clot retrieved few minutes after study procedure ended.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start26 Aug 2021
- Primary completion13 Apr 2024
- Study completion16 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensome
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Cheung, MD, Principal investigator, Liverpool Hospital, Liverpool NSW, AustraliaDennis Cordato, MD, Principal investigator, Liverpool Hospital, Liverpool NSW, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993079
- Sponsor's protocol ID
- SEN_CLOTILD_FIH_1
- Acronym
- CLOTOUT
- Status last verified
- Feb 2026
- First submitted
- 1 Sep 2020
- Last updated
- 27 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clotild® Smart Guidewire System Evaluation in Endovascular Thrombectomy Procedure
- ClinicalTrials.gov ID
- NCT04993079
- Acronym / sponsor ID
- CLOTOUT / SEN_CLOTILD_FIH_1
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- SensomeIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 13 Apr 2024 (actual)
- Study completion
- 16 Apr 2024 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Posted 23 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clotild® | Experimental | Device: Clotild® Smart Guidewire System (CSGS)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke eligible for EVT
- M1 and/or MCA bifurcation arterial occlusion on Computed tomography angiography (CTA) or MRA (Magnetic resonance angiography) of an intracranial vessel amenable to EVT
- 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.
Key exclusion criteria (4 listed)
- Patient having an intracranial occlusion other than M1 and/or MCA bifurcation, especially tandem occlusion and ICA (internal carotid artery) occlusion.
- 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
- Candidates not eligible for EVT based on neurointerventionist and/or neurologist investigators' opinion
- Pregnancy or lactating subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clotild® Smart Guidewire System (CSGS)Use of Clotild® Smart Guidewire System as neurovascular guidewire | Device | Clotild® |
Primary outcome
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 and up to 24hr follow-up (when the 24hr images are taken)
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.
The Ability to Perform Binary Classification of Individual Electrophysiological Parameter Measurements by Distinguishing Local Regions With Substantial Versus Negligible RBC Content in the Occlusion
Time frame: Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject)
* The performance of the CSGS model will be assessed by the performance metric Area Under the Receiver Operator Characteristic curve (AUC of ROC) computed from the RBC-content score predicted on the validation dataset only. * The ROC curve will be defined by the sensitivity (true positive rate) on the Y-axis and 1- specificity (false positive rate) on the X-axis. The ground truth is defined as the binary classification of the local regions into RBC-positive or RBC-negative content performed by SENSOME experts. * The comparator will be the binary classification score determined by the CSGS model. The CSGS model will be developed using interventions from the development phase (Development Performance Population) while it will be validated on the impedance data from the validation phase (Local-Scale Performance Population).
7 secondary outcomes
1. The Concordance Between Aggregated Occlusion Measurements (Clot-scale) Done by CSGS, and the Histology (i.e., Histopathology) Results of the Clot Retrieved During the EVT Procedure, Regarding Red Blood Cell Content in the Occlusion,
Time frame: Occlusion Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject). Clot retrieved few minutes after study procedure ended.
2. The Ability of CSGS to Detect the Proximal End of the Occlusion (Sensor-scale), as Compared to the Physician's Labelling (Tag 'PRE CLOT' for no Occlusion Contact and Tag 'CLOT' for Occlusion Contact),
Time frame: Measurements taken by the investigator during the first few minutes of the study procedure
3. Procedural Success Defined as the Ability to Navigate CSGS to the Occlusion Site and Measure Electrophysiological Properties of the Occlusion,
Time frame: Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject
4. The Ability to Perform Binary Classification of Individual Electrophysiological Parameter Measurements (Local-scale) by Distinguishing Local Regions With Substantial Platelet Content From Regions With Negligible Platelet Content in the Occlusion,
Time frame: Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject
5. The Concordance Between Aggregated Occlusion Measurements (Clot-scale) Done by CSGS, and the Histology Results of the Clot Retrieved During the EVT Procedure, Regarding Platelet Content in the Occlusion,
Time frame: Occlusion Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject). Clot retrieved few minutes after study procedure ended.
6. The Ability to Perform Binary Classification of Individual Electrophysiological Parameter Measurements (Local-scale) by Distinguishing Local Regions With Substantial Fibrin Content From Regions With Negligible Fibrin Content in the Occlusion,
Time frame: Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject)
7. The Concordance Between Aggregated Occlusion Measurements (Clot-scale) Done by CSGS, and the Histology Results of the Clot Retrieved During the EVT Procedure, Regarding Fibrin Content in the Occlusion.
Time frame: Occlusion Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject). Clot retrieved few minutes after study procedure ended.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Cheung, MD principal investigator
Liverpool Hospital, Liverpool NSW, Australia
Dennis Cordato, MD principal investigator
Liverpool Hospital, Liverpool NSW, Australia
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clotild® Smart Guidewire System (CSGS) in people with Stroke, run by Sensome at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 and up to 24hr follow-up (when the 24hr images are taken)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.