Trial Outcomes & Findings for Clotild® Smart Guidewire System (CSGS) Evaluation in EndovascUlar Thrombectomy Procedure (NCT NCT04993079)

Last Updated: 2026-01-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

45 participants

Primary outcome timeframe

Measured during the procedure and up to 24hr follow-up (when the 24hr images are taken)

Results posted on

2026-01-23

Participant Flow

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

Eligibility check is in 2 steps - at the time of screening (and consenting), few patients got medication to resolve the clot. As the study device's purpose is to evaluate clot composition, a 2nd eligibility check is done just prior the study procedure - 4 patients did not meet this additional check. In France in emergency cases - regulations allow that consent is taken after the procedure. Two subjects did not provide it. Only safety data collected in these 2 subjects, no performance data

Participant milestones

Participant milestones
Measure	Single Arm A total of 45 subjects were enrolled in the investigation, comprising 15, 18 and 12 subjects from the different centers participating in the study. As per the investigation's endpoints, different analytical populations were defined. Thus, 41 subjects constituted the safety population, 39 subjects the per-protocol population, while 26 subjects were included in the performance population.
Overall Study STARTED	45
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm A total of 45 subjects were enrolled in the investigation, comprising 15, 18 and 12 subjects from the different centers participating in the study. As per the investigation's endpoints, different analytical populations were defined. Thus, 41 subjects constituted the safety population, 39 subjects the per-protocol population, while 26 subjects were included in the performance population.
Overall Study Screen Failure	4
Overall Study Failure to provide full consent	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=45 Participants 45 subjects were selected for study participation at 3 (2 in Australia / 1 in France) Investigational Sites. 41 met the second eligibility check, immediately after skin puncture was performed (treated population). 39 are included in the per-protocol population, as in France, per regulatory procedures, patients could provide consent after the study procedure - however, 2 patients did not give consent.
Age, Continuous	75.4 years n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Sex: Female, Male Female	20 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Sex: Female, Male Male	19 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Race (NIH/OMB) Asian	4 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Race (NIH/OMB) Black or African American	1 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Race (NIH/OMB) White	22 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Race (NIH/OMB) More than one race	2 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Region of Enrollment Australia	33 participants n=45 Participants
Region of Enrollment France	12 participants n=45 Participants
BMI Underweight (BMI<18.5 kg/m2)	1 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
BMI Normal weight (18.5≤BMI<25 kg/m2)	12 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
BMI Overweight (25≤BMI<30 kg/m2)	7 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
BMI Obese (BMI≥30 kg/m2)	7 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
BMI Missing	12 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Blood Pressure Optimal (SBP <120 mmHg and DBP <80 mmHg)	4 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Blood Pressure Normal (SBP between 120-129 mmHg and/or DBP between 80-84 mmHg)	5 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Blood Pressure High-normal (SBP between 130-139 mmHg and/or DBP between 85-89 mmHg)	8 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Blood Pressure Grade 1 hypertension (SBP between 140-159 mmHg and/or DBP between 90-99 mmHg)	10 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Blood Pressure Grade 2 hypertension (SBP between 160-179 mmHg and/or DBP between 100-109 mmHg)	5 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Blood Pressure Grade 3 hypertension (SBP ≥180 and/or DBP ≥110 mmHg)	6 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Blood Pressure Missing	1 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
ECG results Normal	13 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
ECG results Abnormal - not clinically significant	11 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
ECG results Abnormal - clinically significant	9 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
ECG results Missing	6 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Smoking Never used	20 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Smoking No use within the last 10 years	3 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Smoking No use within the last 12 months	5 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Smoking Current user	4 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Smoking Missing	1 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Smoking Not documented	6 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Alcohol consumption Never used	14 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Alcohol consumption No use within the last 12 months	2 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Alcohol consumption Current user	10 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Alcohol consumption Missing	2 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Alcohol consumption Not documented	11 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Dislipidemia Yes	8 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Dislipidemia NO	31 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Coronary Artery Disease YES	5 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Coronary Artery Disease NO	34 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Arrhythmia YES	16 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Arrhythmia NO	23 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Renal Dysfunction YES	4 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Renal Dysfunction NO	35 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
COPD YES	4 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
COPD NO	35 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Previous ischemic stroke / TIA YES	7 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Previous ischemic stroke / TIA NO	32 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Previous hemorrhagic stroke YES	1 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Previous hemorrhagic stroke NO	38 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Diabetes YES	8 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Diabetes NO	31 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
NIHSS Minor stroke (1-4)	2 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
NIHSS Moderate stroke (5-15)	18 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
NIHSS Moderate to severe stroke (16-20)	10 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
NIHSS Severe stroke (21-42)	8 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
NIHSS Missing	1 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
GCS 8-10	5 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
GCS >10	30 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
GCS Missing	4 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Thrombolytic medication YES	14 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)
Thrombolytic medication NO	25 Participants n=39 Participants • This parameter will only be displayed for the Per Protocol Population (39 subjects)

PRIMARY outcome

Timeframe: Measured during the procedure and up to 24hr follow-up (when the 24hr images are taken)

Outcome measures

Outcome measures
Measure	Single Center n=41 Participants 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). The safety population consisted thus out of 41 subjects
The Proportion of Patients Having Intracranial Vessel Perforation and / or Dissection Due to Clotild® Usage at the Site of Usage in Intracranial Vessels	0 Participants

PRIMARY outcome

Timeframe: Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject)

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.

* 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).

Outcome measures

Outcome measures
Measure	Single Center n=15 Participants 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). The safety population consisted thus out of 41 subjects
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 Probability (AUC of ROC curve) Interval 0.93 to 0.99

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Single Center n=15 Participants 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). The safety population consisted thus out of 41 subjects
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 percentage per unit of percentage Interval -0.79 to 1.18

SECONDARY outcome

Timeframe: Measurements taken by the investigator during the first few minutes of the study procedure

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

Outcome measures

Outcome measures
Measure	Single Center n=15 Participants 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). The safety population consisted thus out of 41 subjects
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 Probability (AUC of ROC curve) Interval 0.44 to 0.85

SECONDARY outcome

Timeframe: Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject

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.

Outcome measures

Outcome measures
Measure	Single Center n=39 Participants 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). The safety population consisted thus out of 41 subjects
3. Procedural Success Defined as the Ability to Navigate CSGS to the Occlusion Site and Measure Electrophysiological Properties of the Occlusion,	26 Participants

SECONDARY outcome

Timeframe: Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject

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 - 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.

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.

Outcome measures

Outcome measures
Measure	Single Center n=15 Participants 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). The safety population consisted thus out of 41 subjects
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 Probability (AUC of ROC curve) Interval 0.89 to 0.98

SECONDARY outcome

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

Outcome measures

Outcome measures
Measure	Single Center n=15 Participants 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). The safety population consisted thus out of 41 subjects
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 percentage per unit of percentage Interval -2.57 to 0.65

SECONDARY outcome

Timeframe: Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject)

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 - 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.

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.

Outcome measures

Outcome measures
Measure	Single Center n=15 Participants 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). The safety population consisted thus out of 41 subjects
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 Probability (AUC of ROC curve) Interval 0.36 to 0.46

SECONDARY outcome

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.

Outcome measures

Outcome measures
Measure	Single Center n=15 Participants 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). The safety population consisted thus out of 41 subjects
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 percentage per unit of percentage Interval -0.98 to 1.2

Adverse Events

Single Arm

Serious events: 11 serious events

Other events: 9 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm n=41 participants at risk A total of 45 subjects were enrolled in the investigation, comprising 33 from Australia and 12 from France. Four subjects did not confirn the eligibility criteria at the time of the study procedure (screen failure). The safety population consisted out of 41 subjects
Nervous system disorders Hemorrhagic transformation stroke	2.4% 1/41 • Number of events 1 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.
Nervous system disorders Cerebral artery occlusion	2.4% 1/41 • Number of events 1 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.
Nervous system disorders Hemorrhage intracranial	2.4% 1/41 • Number of events 1 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.
Nervous system disorders Stroke in evolution	2.4% 1/41 • Number of events 1 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.4% 1/41 • Number of events 1 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.4% 1/41 • Number of events 1 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.
Respiratory, thoracic and mediastinal disorders Respiratory failure	2.4% 1/41 • Number of events 1 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.
Injury, poisoning and procedural complications Contrast encephalopathy	2.4% 1/41 • Number of events 1 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.
General disorders Puncture site hematoma	2.4% 1/41 • Number of events 1 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.
General disorders General physical health deterioration	2.4% 1/41 • Number of events 1 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.
Vascular disorders Arterial occlusive disease	2.4% 1/41 • Number of events 1 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.
Vascular disorders Labile blood pressure	2.4% 1/41 • Number of events 1 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.
Cardiac disorders Acute myocardial infarction	2.4% 1/41 • Number of events 1 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.
Surgical and medical procedures Oxygen therapy	2.4% 1/41 • Number of events 1 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.

Other adverse events

Other adverse events
Measure	Single Arm n=41 participants at risk A total of 45 subjects were enrolled in the investigation, comprising 33 from Australia and 12 from France. Four subjects did not confirn the eligibility criteria at the time of the study procedure (screen failure). The safety population consisted out of 41 subjects
Nervous system disorders Subarachnoid hemorrhage	7.3% 3/41 • Number of events 3 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.
Nervous system disorders Hemorrhagic transformation stroke	2.4% 1/41 • Number of events 1 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.
Nervous system disorders Cerebral hematoma	2.4% 1/41 • Number of events 1 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.
Nervous system disorders Cerebral hemorrhage	2.4% 1/41 • Number of events 1 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.4% 1/41 • Number of events 1 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.
Injury, poisoning and procedural complications Weaning failure	2.4% 1/41 • Number of events 1 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.
Injury, poisoning and procedural complications Delayed recovery from anesthesia	2.4% 1/41 • Number of events 1 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.
General disorders Edema peripheral	2.4% 1/41 • Number of events 1 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.
Gastrointestinal disorders Tongue hematoma	2.4% 1/41 • Number of events 1 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.
Gastrointestinal disorders Acquired macroglossia	2.4% 1/41 • Number of events 1 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.
Cardiac disorders Atrial fibrillation	2.4% 1/41 • Number of events 1 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.
Infections and infestations Urinary tract infection	4.9% 2/41 • Number of events 2 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.
Metabolism and nutrition disorders Hypercholesterolemia	2.4% 1/41 • Number of events 1 • 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) Confirmation of eligibility for study participation was a 2 step process. At the time of screening, the subjects was evaluated for study participation and Informed Consent was obtained. Once at the start of the EVT procedure, it was assessed if patient was still eligibile for study participation. Adverse Event reporting started once the subjects eligibility for study participation was confirmed.

Additional Information

Clinical Lead

Sensome

Phone: +33185370770

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place