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

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.

Time frame: 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.

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).

Time frame: Baseline (Day 0, before procedure) up to 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.

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.

Time frame: 90 days 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.

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.

Time frame: 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.

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).

Time frame: 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.

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.

Time frame: 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 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.

Time frame: 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 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.

Time frame: at Day 90

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.

Time frame: 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 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.

Time frame: 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.

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.

Time frame: 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.