Trial Outcomes & Findings for Prospective Evaluation to Characterize the Real-World Performance of the EMBOVAC Aspiration Catheter (NCT NCT04531904)

NCT ID: NCT04531904

Last Updated: 2024-01-26

Results Overview

Successful revascularization was defined as achieving a final modified thrombolysis in cerebral infarction (mTICI) score of 2b or greater in target vessel. Revascularization was measured by an independent adjudicating imaging core laboratory and were reported using expanded treatment in cerebral infarction (eTICI) scale. eTICI was a 7-point grading system for determining response of thrombolytic therapy for ischemic stroke: 0=No reperfusion; 0 percent(%) filling of downstream territory; 1=Thrombus reduction without any reperfusion of distal arteries; 2a=Reperfusion in less than half (1-49%) of the territory; 2b=2b50 (reperfusion in \[50-66%\] of downstream territory) and 2b67 (reperfusion in (67-89%) of downstream territory); 2c=Reperfusion in \[90-99%\] of downstream territory; 3=Complete and 100% reperfusion where higher score indicated more successful revascularization.

Recruitment status

COMPLETED

Target enrollment

102 participants

Primary outcome timeframe

Day 0 (post-procedure)

Results posted on

2024-01-26

Participant Flow

Participant milestones

Participant milestones
Measure	EMBOVAC Aspiration Catheter Participants with acute ischemic stroke evaluated by the physician (in accordance with their institutional practice) were attempted with EMBOVAC aspiration catheter or aspiration procedure was performed on Day 0.
Overall Study STARTED	102
Overall Study Attempted EmboVac Procedure But Not Performed	2
Overall Study COMPLETED	87
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	EMBOVAC Aspiration Catheter Participants with acute ischemic stroke evaluated by the physician (in accordance with their institutional practice) were attempted with EMBOVAC aspiration catheter or aspiration procedure was performed on Day 0.
Overall Study Lost to Follow-up	1
Overall Study Death	14

Baseline Characteristics

Prospective Evaluation to Characterize the Real-World Performance of the EMBOVAC Aspiration Catheter

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EMBOVAC Aspiration Catheter n=102 Participants Participants with acute ischemic stroke evaluated by the physician (in accordance with their institutional practice) were attempted with EMBOVAC aspiration catheter or aspiration procedure was performed on Day 0.
Age, Continuous	70.6 Years STANDARD_DEVIATION 13.86 • n=5 Participants
Sex: Female, Male Female	61 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	50 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 (post-procedure)

Population: The modified intent-to-treat (mITT) analysis set consisted of enrolled participants who received treatment (at least one pass; a pass was defined as use of aspiration followed by evaluation of revascularization with angiography) with the study device. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

Outcome measures

Outcome measures
Measure	EMBOVAC Aspiration Catheter n=99 Participants Participants with acute ischemic stroke evaluated by the physician (in accordance with their institutional practice) were attempted with EMBOVAC aspiration catheter or aspiration procedure was performed on Day 0.
Percentage of Participants With Successful Revascularization	98.0 Percentage of participants Interval 92.9 to 99.8

SECONDARY outcome

Timeframe: Day 0

Population: The mITT analysis set consisted of enrolled participants who received treatment (at least one pass; a pass was defined as use of aspiration followed by evaluation of revascularization with angiography) with the study device. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

Percentage of participants with successful revascularization without rescue therapy was reported. In this outcome measure, successful revascularization was defined as achieving a final mTICI score of 2b or greater in the target vessel as determined by the Independent Imaging Core Laboratory without use of rescue therapy.

Outcome measures

Outcome measures
Measure	EMBOVAC Aspiration Catheter n=99 Participants Participants with acute ischemic stroke evaluated by the physician (in accordance with their institutional practice) were attempted with EMBOVAC aspiration catheter or aspiration procedure was performed on Day 0.
Percentage of Participants With Successful Revascularization Without Rescue Therapy	87.9 Percentage of participants Interval 79.8 to 93.6

SECONDARY outcome

Timeframe: Day 0

Complete revascularization was defined as achieving a final mTICI score of 2c or greater in the target vessel as determined by the Independent Imaging Core Laboratory. Revascularization was measured by an independent adjudicating imaging core laboratory and were reported using expanded treatment in cerebral infarction(eTICI) scale. eTICI was a 6-point grading system for determining response of thrombolytic therapy for ischemic stroke:0=No reperfusion; 0 percent (%) filling of downstream territory;1=Thrombus reduction without any reperfusion of distal arteries;2a=Reperfusion in less than half (1-49%) of territory; 2b=2b50 (reperfusion in \[50-66%\] of downstream territory) and 2b67 (reperfusion in (67-89%) of downstream territory);2c=Reperfusion in \[90-99%\] of downstream territory;3=Complete and 100% reperfusion where higher score indicated successful revascularization.

Outcome measures

Outcome measures
Measure	EMBOVAC Aspiration Catheter n=99 Participants Participants with acute ischemic stroke evaluated by the physician (in accordance with their institutional practice) were attempted with EMBOVAC aspiration catheter or aspiration procedure was performed on Day 0.
Percentage of Participants With Complete Revascularization	86.9 Percentage of participants Interval 78.6 to 92.8

SECONDARY outcome

Timeframe: Day 0

Percentage of participants with first pass effect without rescue therapy (mTICI score of 2c or greater after the first pass with the EMBOVAC Aspiration Catheter as determined by the Independent Imaging Core Laboratory) was reported. First pass effect was described as a complete revascularization obtained after a single device pass with no rescue therapy.

Outcome measures

Outcome measures
Measure	EMBOVAC Aspiration Catheter n=99 Participants Participants with acute ischemic stroke evaluated by the physician (in accordance with their institutional practice) were attempted with EMBOVAC aspiration catheter or aspiration procedure was performed on Day 0.
Percentage of Participants With First Pass Effect Without Rescue Therapy	53.5 Percentage of participants Interval 43.2 to 63.6

SECONDARY outcome

Timeframe: Day 0

Percentage of participants with modified first pass effect was reported. Modified first pass effect was defined as mTICI of 2b or greater after the first pass with the EMBOVAC aspiration catheter as determined by the Independent Imaging Core Laboratory.

Outcome measures

Outcome measures
Measure	EMBOVAC Aspiration Catheter n=99 Participants Participants with acute ischemic stroke evaluated by the physician (in accordance with their institutional practice) were attempted with EMBOVAC aspiration catheter or aspiration procedure was performed on Day 0.
Percentage of Participants With Modified First Pass Effect	72.7 Percentage of participants Interval 62.9 to 81.2

SECONDARY outcome

Timeframe: Day 0

Time (in minutes) to recanalization (reopening of a previously occluded passageway within a blood vessel) was defined as the procedure time from arterial puncture to recanalization (achievement of the first mTICI score \>=2b as determined by the core laboratory) or visualization of final angiographic result if an mTICI score of 2b or greater was not achieved".

Outcome measures

Outcome measures
Measure	EMBOVAC Aspiration Catheter n=71 Participants Participants with acute ischemic stroke evaluated by the physician (in accordance with their institutional practice) were attempted with EMBOVAC aspiration catheter or aspiration procedure was performed on Day 0.
Time to Recanalization	27.8 Minutes Standard Deviation 20.58

SECONDARY outcome

Timeframe: at Day 90

Percentage of participants with mRS scores 0 to 2 at 90 days was reported. The mRS is a scale commonly used to measure the degree of disability or dependence in the daily activities in participants following stroke or other neurological event. It was a 7-point scale that ranged from 0 to 6 where 0=no symptoms at all; 1=no significant disability despite symptoms; 2=slight disability; 3=moderate disability; 4=moderately severe disability; 5=severe disability; 6=death. A lower number indicated lower disability. The mRS evaluation at 90 days was performed by an independent assessor.

Outcome measures

Outcome measures
Measure	EMBOVAC Aspiration Catheter n=99 Participants Participants with acute ischemic stroke evaluated by the physician (in accordance with their institutional practice) were attempted with EMBOVAC aspiration catheter or aspiration procedure was performed on Day 0.
Percentage of Participants With Modified Rankin Scale (mRS) Scores 0 to 2 at Day 90	56.6 Percentage of participants Interval 46.2 to 66.5

SECONDARY outcome

Timeframe: Up to Day 90 post procedure on Day 0

Population: The safety analysis set consisted of all enrolled participants in whom the procedure was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.

SAE was any untoward medical occurrence that at any dose may result in death,life-threatening illness or injury, permanent impairment of body structure or body function including chronic diseases, in-patient or prolonged hospitalization, medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to body structure or body function, fetal distress, fetal death or congenital abnormality or birth defect including physical or mental impairment. Serious adverse device effect was adverse device effect that was resulted in any of consequences characteristic of SAE. Any device related serious adverse event associated with the use of EMBOVAC Aspiration Catheter (or cannot be ruled out as having caused the event) up to 90 days post index stroke procedure. Device relatedness was adjudicated by an independent Clinical Events Committee (CEC).

Outcome measures

Outcome measures
Measure	EMBOVAC Aspiration Catheter n=102 Participants Participants with acute ischemic stroke evaluated by the physician (in accordance with their institutional practice) were attempted with EMBOVAC aspiration catheter or aspiration procedure was performed on Day 0.
Percentage of Participants With Device Related Serious Adverse Events (SAEs)	1.0 Percentage of participants Interval 0.1 to 6.8

SECONDARY outcome

Timeframe: 24 hours post procedure on Day 0

Population: The safety analysis set consisted of all enrolled participants in whom the procedure was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside of the participant. Here 'N' (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.

Percentage of participants with sICH according to Heidelberg Bleeding Classification at 24 hours (hr) post procedure was reported. sICH:new intracranial hemorrhage detected by brain imaging (measured 24 hr post intervention) associated with any of item:\>=4 points total National Institute of Health Stroke Scale (NIHSS:tool used by healthcare providers to objectively quantify impairment caused by stroke) at time of diagnosis compared to immediately before worsening; \>=2 point in 1 NIHSS category. Rationale:to capture new hemorrhages that produced new neurological symptoms, making it clearly symptomatic but not causing worsening in original stroke territory; lead to intubation/hemicraniectomy/external ventricular drain placement or other major medical/surgical intervention or absence of alternative explanation for deterioration. Independent imaging core laboratory reviewed all 24 hr imaging to identify all ICH. Independent Clinical Events Committee judged ICH as symptomatic/asymptomatic.

Outcome measures

Outcome measures
Measure	EMBOVAC Aspiration Catheter n=101 Participants Participants with acute ischemic stroke evaluated by the physician (in accordance with their institutional practice) were attempted with EMBOVAC aspiration catheter or aspiration procedure was performed on Day 0.
Percentage of Participants With Symptomatic Intracerebral Hemorrhage (sICH)	0 Percentage of participants Interval 0.0 to 3.6

SECONDARY outcome

Timeframe: Baseline (Day 0, before procedure) up to 24 hours post procedure on Day 0

Change from baseline in NIHSS total Score at 24 hours post procedure was reported. NIHSS is an assessment which objectively quantifies the impairment caused by stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between a 0 and 4. For each item, 0=normal function in that specific ability, while a higher score (4)=some level of impairment. The individual scores from each item are summed in order to calculate a participant's total NIHSS score. The participant's total NIHSS score ranges from 0 (minimum) - 42 (maximum). Score 0 (no stroke symptoms); 1 - 4 (Minor stroke); 5-15 (Moderate stroke); 16-20 (Moderate to severe stroke); and 21-42 (Severe stroke).

Outcome measures

Outcome measures
Measure	EMBOVAC Aspiration Catheter n=101 Participants Participants with acute ischemic stroke evaluated by the physician (in accordance with their institutional practice) were attempted with EMBOVAC aspiration catheter or aspiration procedure was performed on Day 0.
Change From Baseline in National Institutes of Health Stroke Scale (NIHSS) Total Score at 24 Hours Post-procedure	-6.9 Scores on a scale Standard Deviation 6.36

SECONDARY outcome

Timeframe: 90 days post procedure on Day 0

Number of participants with all-cause mortality through 90 days post procedure was reported. All-cause mortality included all deaths of participants due to any cause. Participants without events were censored at the date of last contact in the study.

Outcome measures

Outcome measures
Measure	EMBOVAC Aspiration Catheter n=102 Participants Participants with acute ischemic stroke evaluated by the physician (in accordance with their institutional practice) were attempted with EMBOVAC aspiration catheter or aspiration procedure was performed on Day 0.
Number of Participants With All-Cause Mortality Thorugh 90 Days	13 Participants

Adverse Events

EMBOVAC Aspiration Catheter

Serious events: 26 serious events

Other events: 17 other events

Deaths: 14 deaths

Serious adverse events

Serious adverse events
Measure	EMBOVAC Aspiration Catheter n=102 participants at risk Participants with acute ischemic stroke evaluated by the physician (in accordance with their institutional practice) were attempted with EMBOVAC aspiration catheter or aspiration procedure was performed on Day 0.
Nervous system disorders Cerebral artery occlusion	2.0% 2/102 • Number of events 2 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Nervous system disorders Cerebral haemorrhage	2.0% 2/102 • Number of events 2 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Nervous system disorders Haemorrhage intracranial	2.0% 2/102 • Number of events 2 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Nervous system disorders Haemorrhagic transformation stroke	2.0% 2/102 • Number of events 2 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Nervous system disorders Brain oedema	0.98% 1/102 • Number of events 1 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Nervous system disorders Stroke in evolution	0.98% 1/102 • Number of events 1 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Infections and infestations Pneumonia	2.9% 3/102 • Number of events 3 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Infections and infestations Sepsis	2.0% 2/102 • Number of events 2 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Infections and infestations Endocarditis	0.98% 1/102 • Number of events 1 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Infections and infestations Urosepsis	0.98% 1/102 • Number of events 1 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Cardiac disorders Atrial fibrillation	2.0% 2/102 • Number of events 2 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Cardiac disorders Atrioventricular block	0.98% 1/102 • Number of events 1 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Cardiac disorders Cardiac arrest	0.98% 1/102 • Number of events 1 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Cardiac disorders Sinus node dysfunction	0.98% 1/102 • Number of events 1 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.9% 4/102 • Number of events 4 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.98% 1/102 • Number of events 1 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Injury, poisoning and procedural complications Intraoperative cerebral artery occlusion	2.0% 2/102 • Number of events 2 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Injury, poisoning and procedural complications Vascular access site occlusion	0.98% 1/102 • Number of events 1 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Injury, poisoning and procedural complications Vascular access site pseudoaneurysm	0.98% 1/102 • Number of events 1 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Gastrointestinal disorders Diverticulum intestinal	0.98% 1/102 • Number of events 1 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Gastrointestinal disorders Pharyngo-oesophageal diverticulum	0.98% 1/102 • Number of events 1 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
General disorders Death	2.0% 2/102 • Number of events 2 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Metabolism and nutrition disorders Hyponatraemia	0.98% 1/102 • Number of events 1 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Vulval cancer	0.98% 1/102 • Number of events 1 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.

Other adverse events

Other adverse events
Measure	EMBOVAC Aspiration Catheter n=102 participants at risk Participants with acute ischemic stroke evaluated by the physician (in accordance with their institutional practice) were attempted with EMBOVAC aspiration catheter or aspiration procedure was performed on Day 0.
Nervous system disorders Haemorrhagic transformation stroke	8.8% 9/102 • Number of events 9 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Nervous system disorders Subarachnoid haemorrhage	2.0% 2/102 • Number of events 2 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Nervous system disorders Cerebral artery perforation	0.98% 1/102 • Number of events 1 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Nervous system disorders Cerebral microhaemorrhage	0.98% 1/102 • Number of events 1 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Nervous system disorders Intraventricular haemorrhage	0.98% 1/102 • Number of events 1 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Nervous system disorders Migraine	0.98% 1/102 • Number of events 1 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Nervous system disorders Syncope	0.98% 1/102 • Number of events 1 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Vascular disorders Air embolism	0.98% 1/102 • Number of events 1 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Vascular disorders Hypotension	0.98% 1/102 • Number of events 1 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Injury, poisoning and procedural complications Vascular access site haematoma	2.0% 2/102 • Number of events 2 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Psychiatric disorders Organic brain syndrome	0.98% 1/102 • Number of events 1 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.
Vascular disorders Vasospasm	0.98% 1/102 • Number of events 1 • Serious adverse events and Other adverse events (Non-serious): Up to Day 90; for all-cause mortality: From Day 0 to end of the study (i.e., up to 21.3 months ) The safety analysis set consist of all enrolled participants in whom the treatment was attempted, defined by the advancement of the EMBOVAC Aspiration Catheter inside the participant.

Additional Information

Cerenovus Clinical Research Director

CERENOVUS

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Draft abstracts, manuscripts, and materials for presentation at scientific meetings must be sent to the sponsor at least 60 working days prior to abstract or other relevant submission deadlines. Authorship of publications resulting from this study was based on generally accepted criteria for major medical journals.
Publication restrictions are in place

Restriction type: OTHER