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

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.

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.

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

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.

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.

This parameter will only be displayed for the Per Protocol Population (39 subjects)

Not Collected in France as per local country regulations

This parameter will only be displayed for the Per Protocol Population (39 subjects)

For 12 participants, BMI could not be calculated as patient's height was not documented.

This parameter will only be displayed for the Per Protocol Population (39 subjects)

This parameter will only be displayed for the Per Protocol Population (39 subjects)

This parameter will only be displayed for the Per Protocol Population (39 subjects)

This parameter will only be displayed for the Per Protocol Population (39 subjects)

This parameter will only be displayed for the Per Protocol Population (39 subjects)

This parameter will only be displayed for the Per Protocol Population (39 subjects)

This parameter will only be displayed for the Per Protocol Population (39 subjects)

This parameter will only be displayed for the Per Protocol Population (39 subjects)

This parameter will only be displayed for the Per Protocol Population (39 subjects)

This parameter will only be displayed for the Per Protocol Population (39 subjects)

This parameter will only be displayed for the Per Protocol Population (39 subjects)

This parameter will only be displayed for the Per Protocol Population (39 subjects)

This parameter will only be displayed for the Per Protocol Population (39 subjects)

National Institutes of Health Stroke Scale

This parameter will only be displayed for the Per Protocol Population (39 subjects)

The Glasgow Coma Scale (GCS) is a neurological assessment tool used to determine a person's level of consciousness, particularly after a head injury.

It assesses three key areas: eye-opening, verbal response, and motor response. Each area is given a score, and the total score (ranging from 3 to 15) indicates the level of consciousness, with lower scores indicating a more severe impairment

This parameter will only be displayed for the Per Protocol Population (39 subjects)

This parameter will only be displayed for the Per Protocol Population (39 subjects)

• 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).

A total of 45 subjects were enrolled in the investigation. Four subjects did not confirn the eligibility criteria at the time of the study procedure (screen failure) and 2 subjects did not provide full consent. Thus, 41 subjects constituted the safety population, 39 subjects the per-protocol population, while 26 subjects were included in the performance population from which 15 subjects constituted the validation performance population.

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.

A total of 45 subjects were enrolled in the investigation. Four subjects did not confirn the eligibility criteria at the time of the study procedure (screen failure) and 2 subjects did not provide full consent. Thus, 41 subjects constituted the safety population, 39 subjects the per-protocol population, while 26 subjects were included in the performance population from which 15 subjects constituted the validation performance population

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

A total of 45 subjects were enrolled in the investigation. Four subjects did not confirn the eligibility criteria at the time of the study procedure (screen failure) and 2 subjects did not provide full consent. Thus, 41 subjects constituted the safety population, 39 subjects the per-protocol population, while 26 subjects were included in the performance population from which 15 subjects constituted the validation performance population.

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.

A total of 45 subjects were enrolled in the investigation. Four subjects did not confirn the eligibility criteria at the time of the study procedure (screen failure) and 2 subjects did not provide full consent. Thus, 41 subjects constituted the safety population, 39 subjects the per-protocol population,

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.

A total of 45 subjects were enrolled in the investigation. Four 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 analuysed for these subjects.

Thus, 41 subjects constituted the safety population, 39 subjects the per-protocol population, while 26 subjects were included in the performance population from which 15 subjects constituted the validation performance population.

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

A total of 45 subjects were enrolled in the investigation. Four subjects did not confirn the eligibility criteria at the time of the study procedure (screen failure) and 2 subjects did not provide full consent. Thus, 41 subjects constituted the safety population, 39 subjects the per-protocol population, while 26 subjects were included in the performance population from which 15 subjects constituted the validation performance population.

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.

A total of 45 subjects were enrolled in the investigation. Four 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 analuysed for these subjects.

Thus, 41 subjects constituted the safety population, 39 subjects the per-protocol population, while 26 subjects were included in the performance population from which 15 subjects constituted the validation performance population.

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.

A total of 45 subjects were enrolled in the investigation. Four subjects did not confirn the eligibility criteria at the time of the study procedure (screen failure) and 2 subjects did not provide full consent. Thus, 41 subjects constituted the safety population, 39 subjects the per-protocol population, while 26 subjects were included in the performance population from which 15 subjects constituted the validation performance population.