An interventional study of Clotild® Smart Guidewire System (CSGS) in Stroke, sponsored by Sensome. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Sensome · Not applicable, Interventional, and Other
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 45 is close to the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Sensome is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Clotild® Smart Guidewire System (CSGS)
Use of Clotild® Smart Guidewire System as neurovascular guidewire
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.
Time frame: 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).
Time frame: Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject)
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.
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),
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
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,
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.
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,
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.
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,
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
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,
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.
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.
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.
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.
FPI: 6-AUG-2021 LPO: 16-APR-2024. Of the 45 enrolled subjects, four screen failures were documented yielding a safety population (treated population) of 41 individuals. Of those, two subjects did not provide full consent, resulting in 39 individuals within the per-protocol population
| Milestone | Single Arm |
|---|---|
| Started | 45 |
| Completed | 39 |
| Not completed | 6 |
| Withdrew: Screen failure | 4 |
| Withdrew: Failure to provide full consent | 2 |
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.
| Participants | Single Center |
|---|---|
| The Proportion of Patients Having Intracranial Vessel Perforation and / or Dissection Due to Clotild® Usage at the Site of Usage in Intracranial Vessels | 0 |
* 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).
| Probability (AUC of ROC curve) | Single Arm |
|---|---|
| The Ability to Perform Binary Classification of Individual Electrophysiological Parameter Measurements by Distinguishing Local Regions With Substantial Versus Negligible RBC Content in the Occlusion | 0.97 (0.93 to 0.99) |
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.
| percentage per unit of percentage | Single Arm |
|---|---|
| 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, | 0.19 (-0.79 to 1.18) |
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
| Probability (AUC of ROC curve) | Single Arm |
|---|---|
| 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), | 0.66 (0.44 to 0.85) |
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.
| Participants | Single Arm |
|---|---|
| 3. Procedural Success Defined as the Ability to Navigate CSGS to the Occlusion Site and Measure Electrophysiological Properties of the Occlusion, | 26 |
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.
| Probability (AUC of ROC curve) | Single Arm |
|---|---|
| 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, | 0.94 (0.89 to 0.98) |
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
| percentage per unit of percentage | Single Arm |
|---|---|
| 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, | -0.96 (-2.57 to 0.65) |
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.
| Probability (AUC of ROC curve) | Single Arm |
|---|---|
| 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, | 0.41 (0.36 to 0.46) |
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.
| percentage per unit of percentage | Single Arm |
|---|---|
| 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. | 0.11 (-0.98 to 1.20) |
Collected over Adverse Events were collected as from the confirmation of study eligibility (during the EVT) till the end of the last study visit (ie. 24hrs +/- 12hrs). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Arm | 4/41 (9.8%) | 11/41 (26.8%) | 9/41 (22%) |
| Event | Single Arm |
|---|---|
| Hemorrhagic transformation strokeNervous system disorders | 1/41 |
| Cerebral artery occlusionNervous system disorders | 1/41 |
| Hemorrhage intracranialNervous system disorders | 1/41 |
| Stroke in evolutionNervous system disorders | 1/41 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 1/41 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 1/41 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 1/41 |
| Contrast encephalopathyInjury, poisoning and procedural complications | 1/41 |
| Puncture site hematomaGeneral disorders | 1/41 |
| General physical health deteriorationGeneral disorders | 1/41 |
| Event | Single Arm |
|---|---|
| Subarachnoid hemorrhageNervous system disorders | 3/41 |
| Urinary tract infectionInfections and infestations | 2/41 |
| Hemorrhagic transformation strokeNervous system disorders | 1/41 |
| Cerebral hematomaNervous system disorders | 1/41 |
| Cerebral hemorrhageNervous system disorders | 1/41 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 1/41 |
| Weaning failureInjury, poisoning and procedural complications | 1/41 |
| Delayed recovery from anesthesiaInjury, poisoning and procedural complications | 1/41 |
| Edema peripheralGeneral disorders | 1/41 |
| Tongue hematomaGastrointestinal disorders | 1/41 |
45 subjects were enrolled in the investigation 4 subjects did not confirn the eligibility criteria at the time of the study procedure (screen failure) and 2 subjects did not provide full consent - only safety data could be analysed for these subjects.
| Age, Continuous(years) | Single Arm |
|---|---|
| Mean | 75.4 (33 to 97) |
| Sex: Female, Male(Participants) | Single Arm |
|---|---|
| Female | 20 |
| Male | 19 |
| Race (NIH/OMB)(Participants) | Single Arm |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 4 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 22 |
| More than one race | 2 |
| Unknown or Not Reported | 10 |
| Region of Enrollment(participants) | Single Arm |
|---|---|
| Australia | 33 |
| France | 12 |
| BMI(Participants) | Single Arm |
|---|---|
| Underweight (BMI<18.5 kg/m2) | 1 |
| Normal weight (18.5≤BMI<25 kg/m2) | 12 |
| Overweight (25≤BMI<30 kg/m2) | 7 |
| Obese (BMI≥30 kg/m2) | 7 |
| Missing | 12 |
| Blood Pressure(Participants) | Single Arm |
|---|---|
| Optimal (SBP <120 mmHg and DBP <80 mmHg) | 4 |
| Normal (SBP between 120-129 mmHg and/or DBP between 80-84 mmHg) | 5 |
| High-normal (SBP between 130-139 mmHg and/or DBP between 85-89 mmHg) | 8 |
| Grade 1 hypertension (SBP between 140-159 mmHg and/or DBP between 90-99 mmHg) | 10 |
| Grade 2 hypertension (SBP between 160-179 mmHg and/or DBP between 100-109 mmHg) | 5 |
| Grade 3 hypertension (SBP ≥180 and/or DBP ≥110 mmHg) | 6 |
| Missing | 1 |
| ECG results(Participants) | Single Arm |
|---|---|
| Normal | 13 |
| Abnormal - not clinically significant | 11 |
| Abnormal - clinically significant | 9 |
| Missing | 6 |
| Smoking(Participants) | Single Arm |
|---|---|
| Never used | 20 |
| No use within the last 10 years | 3 |
| No use within the last 12 months | 5 |
| Current user | 4 |
| Missing | 1 |
| Not documented | 6 |
12 further baseline measures are reported on the registry.
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