Trial Outcomes & Findings for The Imperative Trial: Treatment of Acute Ischemic Stroke With the Zoom Reperfusion System (NCT NCT04129125)

NCT ID: NCT04129125

Last Updated: 2025-08-08

Results Overview

Reperfusion success was defined as achieving a modified Treatment in Cerebral Infarction (mTICI) score of ≥2b within three or fewer passes using the study device and without rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics). The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (\<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 328 participants
• Primary outcome timeframe: Intraprocedural
• Results posted on: 2025-08-08

Participant Flow

Between October 2021 and March 2024, participants were recruited across 26 institutions in the United States.

Participant milestones

Measure	Zoom Reperfusion System Aspiration thrombectomy using Zoom Reperfusion System
Overall Study STARTED	328
Overall Study COMPLETED	260
Overall Study NOT COMPLETED	68

Reasons for withdrawal

Measure	Zoom Reperfusion System Aspiration thrombectomy using Zoom Reperfusion System
Overall Study Participants did not meet eligibility criteria	65
Overall Study Study device was not used	3

Baseline Characteristics

The Imperative Trial: Treatment of Acute Ischemic Stroke With the Zoom Reperfusion System

Baseline characteristics by cohort

Measure	Zoom Reperfusion System n=260 Participants Aspiration thrombectomy using Zoom Reperfusion System
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	106 Participants n=5 Participants
Age, Categorical >=65 years	154 Participants n=5 Participants
Age, Continuous	68 years n=5 Participants
Sex: Female, Male Female	127 Participants n=5 Participants
Sex: Female, Male Male	133 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	211 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	19 Participants n=5 Participants
Region of Enrollment United States	260 participants n=5 Participants

PRIMARY outcome

Timeframe: Intraprocedural

Population: ITT Cohort: Post thrombectomy imaging available for core lab adjudication.

Reperfusion success was defined as achieving a modified Treatment in Cerebral Infarction (mTICI) score of ≥2b within three or fewer passes using the study device and without rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics). The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.

Outcome measures

Measure	Zoom Reperfusion System n=259 Participants Aspiration thrombectomy using Zoom Reperfusion System
ITT Cohort: Rate of Core Lab-adjudicated Reperfusion Success	216 Participants

PRIMARY outcome

Timeframe: 24-hour post-procedure

Population: ITT Cohort: Post-thrombectomy imaging available for core lab and independent safety board adjudication

Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board

Outcome measures

Measure	Zoom Reperfusion System n=260 Participants Aspiration thrombectomy using Zoom Reperfusion System
ITT Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board	5 Participants

PRIMARY outcome

Timeframe: Intraprocedural

Population: The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter)

Reperfusion success was defined as achieving a modified Treatment in Cerebral Infarction (mTICI) score of ≥2b within three or fewer passes using the study device and without rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics). The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.

Outcome measures

Measure	Zoom Reperfusion System n=211 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort: Rate of Core Lab-adjudicated Reperfusion Success	177 Participants

PRIMARY outcome

Timeframe: 24-hour post-procedure

Population: The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter)

Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board

Outcome measures

Measure	Zoom Reperfusion System n=211 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board	2 Participants

PRIMARY outcome

Timeframe: Intraprocedural

Population: FDA Clearance Cohort - Covariate Analysis for Distal ICA/M1 Occlusions. Procedural imaging was not available for one (1) participant.

Reperfusion success was defined as achieving a modified Treatment in Cerebral Infarction (mTICI) score of ≥2b within three or fewer passes using the study device and without rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics). The mTICI scale ranges from 0 to 3, with higher scores indicating better reperfusion: 0 = no perfusion, 1 = minimal perfusion, 2a = partial (<50%), 2b = substantial (≥50%), 2c = near complete, 3 = complete. This measure reports the number of participants who achieved mTICI ≥2b under these criteria as adjudicated by an independent core lab.

Outcome measures

Measure	Zoom Reperfusion System n=145 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Core Lab-adjudicated Reperfusion Success	125 Participants

PRIMARY outcome

Timeframe: 24-hour post-procedure

Population: FDA Clearance Cohort - Covariate Analysis for Distal ICA/M1 Occlusions; Based on available imaging and NIHSS.

Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board

Outcome measures

Measure	Zoom Reperfusion System n=146 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board	1 Participants

SECONDARY outcome

Timeframe: Intraprocedural

Population: ITT Cohort

The time from groin puncture to mTICI (modified treatment in cerebral infarction) score ≥ 2b

mTICI range: 0 to 3; higher score means better reperfusion

Outcome measures

Measure	Zoom Reperfusion System n=260 Participants Aspiration thrombectomy using Zoom Reperfusion System
ITT Cohort: Time to Achieve mTICI Score ≥ 2b	19 minutes Interval 13.0 to 30.0

SECONDARY outcome

Timeframe: Intraprocedural

Population: ITT Cohort: Post thrombectomy imaging available for core lab adjudication

Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score = 3 within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)

mTICI range: 0 to 3; higher score means better reperfusion

Outcome measures

Measure	Zoom Reperfusion System n=259 Participants Aspiration thrombectomy using Zoom Reperfusion System
ITT Cohort: Rate of mTICI Score 3 Reperfusion	78 Participants

SECONDARY outcome

Timeframe: Intraprocedural

Population: ITT Cohort

Independent core lab-adjudicated modified treatment in cerebral infarction (mTICI) score ≥2b after the first pass with the study device

mTICI range: 0 to 3; higher score means better outcome

Outcome measures

Measure	Zoom Reperfusion System n=259 Participants Aspiration thrombectomy using Zoom Reperfusion System
ITT Cohort: Rate of First Pass Success	148 Participants

SECONDARY outcome

Timeframe: Intraprocedural

Population: ITT Cohort: Post thrombectomy imaging available for core lab adjudication.

Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score ≥2c within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)

mTICI range: 0 to 3; higher score means better outcome

Outcome measures

Measure	Zoom Reperfusion System n=259 Participants Aspiration thrombectomy using Zoom Reperfusion System
ITT Cohort: Rate of mTICI Score 2c Reperfusion	147 Participants

SECONDARY outcome

Timeframe: 90-days post-procedure

Population: ITT Cohort: Subjects with completed mRS assessments

The proportion of patients achieving modified Rankin Scale (mRS) score ≤2 using the primary treatment modality, evaluated by certified assessors

The mRS scale ranges from 0 (no symptoms) to 5 (severe disability), with an additional category of 6 for death

Outcome measures

Measure	Zoom Reperfusion System n=244 Participants Aspiration thrombectomy using Zoom Reperfusion System
ITT Cohort: Rate of Functional Independence	133 Participants

SECONDARY outcome

Timeframe: 90 days post-procedure

Population: ITT Cohort: Participants that completed the SIS Questionnaire

The Stroke Impact Scale (SIS) is a self-reported questionnaire assessing quality of life in 8 domains: Strength, Memory and Thinking, Emotion, Communication, ADL/IADL, Mobility, Hand Function, and Participation/Role Function. Each domain is scored from 0 to 100, with higher scores indicating better function and less impact of stroke. Scores are calculated by averaging item responses in each domain and transforming to a 0-100 scale. A separate recovery score from 0 (no recovery) to 100 (full recovery) reflects the patient's overall perception of recovery. Domain scores are not combined into a total score.

Outcome measures

Measure	Zoom Reperfusion System n=185 Participants Aspiration thrombectomy using Zoom Reperfusion System
ITT Cohort: Quality of Life Assessment Hand Function	68.9 score on a scale Standard Deviation 36
ITT Cohort: Quality of Life Assessment Overall Recovery	71.5 score on a scale Standard Deviation 25.8
ITT Cohort: Quality of Life Assessment Strength	71 score on a scale Standard Deviation 27.9
ITT Cohort: Quality of Life Assessment Memory and Thinking	79.9 score on a scale Standard Deviation 21.9
ITT Cohort: Quality of Life Assessment Emotion	78.9 score on a scale Standard Deviation 17.9
ITT Cohort: Quality of Life Assessment Communication	85 score on a scale Standard Deviation 22.6
ITT Cohort: Quality of Life Assessment Activities of Daily Living or Instrumental Activities of Daily Living	76.3 score on a scale Standard Deviation 28.5
ITT Cohort: Quality of Life Assessment Mobility	71.5 score on a scale Standard Deviation 29.5
ITT Cohort: Quality of Life Assessment Participation/Role Function	70.1 score on a scale Standard Deviation 29.7

SECONDARY outcome

Timeframe: 90 days post-procedure

Population: ITT Cohort

Rate of 90-day all-cause mortality

Outcome measures

Measure	Zoom Reperfusion System n=260 Participants Aspiration thrombectomy using Zoom Reperfusion System
ITT Cohort: Rate of All-Cause Mortality	33 Participants

SECONDARY outcome

Timeframe: 24-hour post-procedure

Population: ITT Cohort: Post thrombectomy imaging available for core lab adjudication.

Independent core lab adjudicated rate of all ICH at 24-hour post-procedure

Outcome measures

Measure	Zoom Reperfusion System n=259 Participants Aspiration thrombectomy using Zoom Reperfusion System
ITT Cohort: Rate of All Intracranial Hemorrhage (ICH)	53 Participants

SECONDARY outcome

Timeframe: 24-hour post-procedure

Population: ITT Cohort: Subjects with completed ENT assessment forms

Rate of participants with embolism into a new territory (ENT) as evidenced by new occlusions noted post-procedure or new infarcts identified on 24-hour imaging that are remote to the vascular territory impacted by the index stroke

Outcome measures

Measure	Zoom Reperfusion System n=246 Participants Aspiration thrombectomy using Zoom Reperfusion System
ITT Cohort: Rate of Embolization in New Territory (ENT)	2 Participants

SECONDARY outcome

Timeframe: 90 days post-procedure

Population: ITT Cohort

Independent Safety Board adjudicated device-related serious adverse device events within 90 days post-procedure

Outcome measures

Measure	Zoom Reperfusion System n=260 Participants Aspiration thrombectomy using Zoom Reperfusion System
ITT Cohort: Rate of Serious Adverse Device Effects (SADEs)	5 Participants

SECONDARY outcome

Timeframe: 90 days post-procedure

Population: ITT Cohort

All serious adverse events through 90 days post-procedure.

Outcome measures

Measure	Zoom Reperfusion System n=260 Participants Aspiration thrombectomy using Zoom Reperfusion System
ITT Cohort: Rate of Serious Adverse Events	95 Participants

SECONDARY outcome

Timeframe: Intraprocedural

Population: The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter)

The time from groin puncture to mTICI (modified treatment in cerebral infarction) score ≥ 2b

mTICI range: 0 to 3; higher score means better reperfusion

Outcome measures

Measure	Zoom Reperfusion System n=211 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort: Time to Achieve mTICI Score ≥ 2b	19 minutes Interval 12.0 to 29.0

SECONDARY outcome

Timeframe: Intraprocedural

Population: The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter)

Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score = 3 within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)

mTICI range: 0 to 3; higher score means better outcome

Outcome measures

Measure	Zoom Reperfusion System n=211 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort: Rate of mTICI Score 3 Reperfusion	65 Participants

SECONDARY outcome

Timeframe: Intraprocedural

Population: The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter)

Independent core lab-adjudicated modified treatment in cerebral infarction (mTICI) score ≥2b after the first pass with the study device

mTICI range: 0 to 3; higher score means better outcome

Outcome measures

Measure	Zoom Reperfusion System n=211 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort: Rate of First Pass Success	128 Participants

SECONDARY outcome

Timeframe: Intraprocedural

Population: The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter)

Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score ≥2c within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)

mTICI range: 0 to 3; higher score means better reperfusion

Outcome measures

Measure	Zoom Reperfusion System n=211 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort: Rate of mTICI Score 2c Reperfusion	124 Participants

SECONDARY outcome

Timeframe: 90-days post-procedure

Population: Subjects with completed mRS assessments. The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter).

The proportion of patients achieving modified Rankin Scale (mRS) score ≤2 using the primary treatment modality, evaluated by certified assessors

The mRS scale ranges from 0 (no symptoms) to 5 (severe disability), with an additional category of 6 for death.

Outcome measures

Measure	Zoom Reperfusion System n=198 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort: Rate of Functional Independence	110 Participants

SECONDARY outcome

Timeframe: 90-days post-procedure

Population: The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter). The sample size includes participants who completed Stroke Impact Scale (SIS) Questionnaire.

The Stroke Impact Scale (SIS) is a self-reported questionnaire assessing quality of life in 8 domains: Strength, Memory and Thinking, Emotion, Communication, ADL/IADL, Mobility, Hand Function, and Participation/Role Function. Each domain is scored from 0 to 100, with higher scores indicating better function and less impact of stroke. Scores are calculated by averaging item responses in each domain and transforming to a 0-100 scale. A separate recovery score from 0 (no recovery) to 100 (full recovery) reflects the patient's overall perception of recovery. Domain scores are not combined into a total score.

Outcome measures

Measure	Zoom Reperfusion System n=146 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort: Quality of Life Assessment Overall Recovery	72.7 score on a scale Standard Deviation 25.7
FDA Clearance Cohort: Quality of Life Assessment Strength	72.4 score on a scale Standard Deviation 27.3
FDA Clearance Cohort: Quality of Life Assessment Memory and Thinking	79.8 score on a scale Standard Deviation 22.6
FDA Clearance Cohort: Quality of Life Assessment Emotion	79.2 score on a scale Standard Deviation 18
FDA Clearance Cohort: Quality of Life Assessment Communication	85.7 score on a scale Standard Deviation 21.7
FDA Clearance Cohort: Quality of Life Assessment Activities of Daily Living or Instrumental Activities of Daily Living	77.8 score on a scale Standard Deviation 28.3
FDA Clearance Cohort: Quality of Life Assessment Mobility	73.8 score on a scale Standard Deviation 28.4
FDA Clearance Cohort: Quality of Life Assessment Hand Function	70.5 score on a scale Standard Deviation 34.9
FDA Clearance Cohort: Quality of Life Assessment Participation/Role Function	70.8 score on a scale Standard Deviation 29.9

SECONDARY outcome

Timeframe: 90-days post-procedure

Population: The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter)

Rate of 90-day all-cause mortality

Outcome measures

Measure	Zoom Reperfusion System n=211 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort: Rate of All-Cause Mortality	26 Participants

SECONDARY outcome

Timeframe: 24-hour post-procedure

Population: The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter). One participant is missing imaging for core lab adjudication.

Independent core lab adjudicated rate of all ICH at 24-hour post-procedure

Outcome measures

Measure	Zoom Reperfusion System n=210 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort: Rate of All Intracranial Hemorrhage (ICH)	42 Participants

SECONDARY outcome

Timeframe: End of procedure to 24-hour post-procedure

Population: The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter). Participants with completed ENT forms are evaluated.

Rate of participants with embolism into a new territory (ENT) as evidenced by new occlusions noted post-procedure or new infarcts identified on 24-hour imaging that are remote to the vascular territory impacted by the index stroke

Outcome measures

Measure	Zoom Reperfusion System n=200 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort: Rate of Embolization in New Territory (ENT)	2 Participants

SECONDARY outcome

Timeframe: 90-days post-procedure

Population: The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter)

Independent Safety Board adjudicated device-related serious adverse device events within 90 days post-procedure

Outcome measures

Measure	Zoom Reperfusion System n=211 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort: Rate of Serious Adverse Device Effects (SADEs)	3 Participants

SECONDARY outcome

Timeframe: 90-days post-procedure

Population: The FDA Clearance Cohort comprises participants in whom concomitant dual aspiration was used (e.g., 0.088" ID and a smaller ID catheter)

All serious adverse events through 90 days post-procedure.

Outcome measures

Measure	Zoom Reperfusion System n=211 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort: Rate of Serious Adverse Events	74 Participants

SECONDARY outcome

Timeframe: Intraprocedural

The time from groin puncture to mTICI (modified treatment in cerebral infarction) score ≥ 2b flow.

mTICI range: 0 to 3; higher score means better reperfusion

Outcome measures

Measure	Zoom Reperfusion System n=145 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Time to Achieve mTICI Score ≥ 2b	18 minutes Interval 12.0 to 27.3

SECONDARY outcome

Timeframe: Intraprocedural

Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score = 3 within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)

mTICI range: 0 to 3; higher score means better reperfusion

Outcome measures

Measure	Zoom Reperfusion System n=145 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of mTICI Score 3 Reperfusion	46 Participants

SECONDARY outcome

Timeframe: Intraprocedural

Independent core lab-adjudicated modified treatment in cerebral infarction (mTICI) score ≥2b after the first pass with the study device

mTICI range: 0 to 3; higher score means better reperfusion

Outcome measures

Measure	Zoom Reperfusion System n=145 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of First Pass Success	87 Participants

SECONDARY outcome

Timeframe: Intraprocedural

Population: Post thrombectomy imaging available for core lab adjudication

Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score ≥2c within three or fewer passes with the study device, without using rescue therapy (e.g., additional thrombectomy devices or intra-arterial lytics)

mTICI range: 0 to 3; higher score means better reperfusion

Outcome measures

Measure	Zoom Reperfusion System n=145 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of mTICI Score 2c Reperfusion	84 Participants

SECONDARY outcome

Timeframe: 90-days post-procedure

Population: Subjects with completed mRS assessments.

The proportion of patients achieving modified Rankin Scale (mRS) score ≤2 using the primary treatment modality, evaluated by certified assessors

The mRS scale ranges from 0 (no symptoms) to 5 (severe disability), with an additional category of 6 for death.

Outcome measures

Measure	Zoom Reperfusion System n=134 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Functional Independence	67 Participants

SECONDARY outcome

Timeframe: 90-days post-procedure

Population: FDA Clearance Cohort - Covariate Analysis for Distal ICA/M1 Occlusions in subjects completing SIS assesment

The Stroke Impact Scale (SIS) is a self-reported questionnaire assessing quality of life in 8 domains: Strength, Memory and Thinking, Emotion, Communication, ADL/IADL, Mobility, Hand Function, and Participation/Role Function. Each domain is scored from 0 to 100, with higher scores indicating better function and less impact of stroke. Scores are calculated by averaging item responses in each domain and transforming to a 0-100 scale. A separate recovery score from 0 (no recovery) to 100 (full recovery) reflects the patient's overall perception of recovery. Domain scores are not combined into a total score.

Outcome measures

Measure	Zoom Reperfusion System n=96 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Quality of Life Assessment Overall Recovery	69 score on a scale Standard Deviation 27
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Quality of Life Assessment Strength	69.4 score on a scale Standard Deviation 28.4
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Quality of Life Assessment Memory and Thinking	76.5 score on a scale Standard Deviation 23.8
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Quality of Life Assessment Emotion	78.6 score on a scale Standard Deviation 17.6
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Quality of Life Assessment Communication	84.7 score on a scale Standard Deviation 23.6
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Quality of Life Assessment Activities of Daily Living or Instrumental Activities of Daily Living	74.6 score on a scale Standard Deviation 29.8
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Quality of Life Assessment Mobility	70 score on a scale Standard Deviation 30
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Quality of Life Assessment Hand Function	66.4 score on a scale Standard Deviation 36.9
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Quality of Life Assessment Participation/Role Function	68.5 score on a scale Standard Deviation 30.9

SECONDARY outcome

Timeframe: 90-days post-procedure

Rate of 90-day all-cause mortality

Outcome measures

Measure	Zoom Reperfusion System n=146 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of All-Cause Mortality	21 Participants

SECONDARY outcome

Timeframe: 24-hour post-procedure

Population: FDA Clearance Cohort - Covariate Analysis for Distal ICA/M1 Occlusions; Based on available imaging: Procedural imaging was not available for one (1) participant.

Independent core lab adjudicated rate of all ICH at 24-hour post-procedure

Outcome measures

Measure	Zoom Reperfusion System n=145 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of All Intracranial Hemorrhage (ICH)	29 Participants

SECONDARY outcome

Timeframe: End of procedure to 24-hour post-procedure

Rate of participants with embolism into a new territory (ENT) as evidenced by new occlusions noted post-procedure or new infarcts identified on 24-hour imaging that are remote to the vascular territory impacted by the index stroke

Outcome measures

Measure	Zoom Reperfusion System n=136 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Embolization in New Territory (ENT)	2 Participants

SECONDARY outcome

Timeframe: 90-days post-procedure

Population: FDA Clearance Cohort - Covariate Analysis for Distal ICA/M1 Occlusions

Independent Safety Board adjudicated device-related serious adverse device events within 90 days post-procedure

Outcome measures

Measure	Zoom Reperfusion System n=146 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Serious Adverse Device Effects (SADEs)	3 Participants

SECONDARY outcome

Timeframe: 90-days post-procedure

All serious adverse events through 90 days post-procedure

Outcome measures

Measure	Zoom Reperfusion System n=146 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Serious Adverse Events	54 Participants

POST_HOC outcome

Timeframe: Intraprocedural

Population: Patients in whom mTICI score ≥2b was achieved

Use of additional devices to achieve core lab adjudicated mTICI score ≥2b

Outcome measures

Measure	Zoom Reperfusion System n=238 Participants Aspiration thrombectomy using Zoom Reperfusion System
ITT Cohort: Rate of Rescue to Achieve mTICI Score ≥2b	13 Participants

POST_HOC outcome

Timeframe: Intraprocedural

Population: Participants in whom mTICI Score ≥ 2b was achieved

Use of additional devices to achieve mTICI Score ≥ 2b

Outcome measures

Measure	Zoom Reperfusion System n=192 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort: Rate of Rescue to Achieve mTICI Score ≥ 2b	9 Participants

POST_HOC outcome

Timeframe: Intraprocedural

Population: Participants in whom mTICI Score ≥ 2b was achieved

Use of additional devices to achieve mTICI Score ≥ 2b

mTICI range: 0 to 3; higher score means better reperfusion

Outcome measures

Measure	Zoom Reperfusion System n=135 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Rescue to Achieve mTICI Score ≥ 2b	5 Participants

POST_HOC outcome

Timeframe: Intraprocedural

Population: FDA Clearance Cohort - Covariate Analysis for Distal ICA/M1 Occlusions

Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score ≥2b, after all passes with the study device. Additional device use after mTICI score ≥2b was achieved with study device was not imputed as failure.

Outcome measures

Measure	Zoom Reperfusion System n=145 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of mTICI Score ≥2b After All Study Device Passes	130 Participants

POST_HOC outcome

Timeframe: Intraprocedural

Population: FDA Clearance Cohort - Covariate Analysis for Distal ICA/M1 Occlusions

Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score ≥2b, after all passes with the study device. Additional device use after mTICI score ≥2b was achieved with study device was imputed as failure.

Outcome measures

Measure	Zoom Reperfusion System n=145 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of mTICI Score ≥2b After All Study Device Passes, Additional Device Use Was Imputed as Failure	126 Participants

POST_HOC outcome

Timeframe: Intraprocedural

Population: FDA Clearance Cohort - Covariate Analysis for Distal ICA/M1 Occlusions

Independent core lab-adjudicated reperfusion success, defined as modified treatment in cerebral infarction (mTICI) score ≥2 at the end of the procedure, including rescue therapy with non-study devices

Outcome measures

Measure	Zoom Reperfusion System n=145 Participants Aspiration thrombectomy using Zoom Reperfusion System
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of mTICI Score ≥2b at the End of the Procedure	135 Participants

Adverse Events

Zoom Reperfusion System

Serious events: 95 serious events

Other events: 165 other events

Deaths: 33 deaths

Serious adverse events

Measure	Zoom Reperfusion System n=260 participants at risk Thrombectomy using Zoom Reperfusion System
Cardiac disorders Atrial fibrillation	1.2% 3/260 • Number of events 3 • Throughout 90 days post-procedure
Cardiac disorders Cardiac arrest	1.5% 4/260 • Number of events 4 • Throughout 90 days post-procedure
Cardiac disorders Cardiac failure	1.2% 3/260 • Number of events 3 • Throughout 90 days post-procedure
Cardiac disorders Cardiac failure acute	1.5% 4/260 • Number of events 4 • Throughout 90 days post-procedure
Gastrointestinal disorders Dysphagia	1.5% 4/260 • Number of events 4 • Throughout 90 days post-procedure
Gastrointestinal disorders Gastrointestinal haemorrhage	1.5% 4/260 • Number of events 4 • Throughout 90 days post-procedure
Infections and infestations Pneumonia	2.7% 7/260 • Number of events 7 • Throughout 90 days post-procedure
Infections and infestations Urinary tract infection	1.5% 4/260 • Number of events 4 • Throughout 90 days post-procedure
Injury, poisoning and procedural complications Vascular pseudoaneurysm	1.2% 3/260 • Number of events 3 • Throughout 90 days post-procedure
Injury, poisoning and procedural complications Vessel perforation	1.2% 3/260 • Number of events 3 • Throughout 90 days post-procedure
Nervous system disorders Brain oedema	3.1% 8/260 • Number of events 8 • Throughout 90 days post-procedure
Nervous system disorders Cerebral artery occlusion	1.2% 3/260 • Number of events 3 • Throughout 90 days post-procedure
Nervous system disorders Cerebral artery restenosis	1.5% 4/260 • Number of events 4 • Throughout 90 days post-procedure
Nervous system disorders Cerebral haemorrhage	1.5% 4/260 • Number of events 4 • Throughout 90 days post-procedure
Nervous system disorders Cerebrovascular accident	2.7% 7/260 • Number of events 7 • Throughout 90 days post-procedure
Nervous system disorders Haemorrhagic transformation stroke	1.9% 5/260 • Number of events 5 • Throughout 90 days post-procedure
Nervous system disorders Seizure	1.5% 4/260 • Number of events 4 • Throughout 90 days post-procedure
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	4.6% 12/260 • Number of events 12 • Throughout 90 days post-procedure
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	2.7% 7/260 • Number of events 7 • Throughout 90 days post-procedure
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.5% 9/260 • Number of events 9 • Throughout 90 days post-procedure

Other adverse events

Measure	Zoom Reperfusion System n=260 participants at risk Thrombectomy using Zoom Reperfusion System
Blood and lymphatic system disorders Anaemia	2.7% 7/260 • Number of events 7 • Throughout 90 days post-procedure
Blood and lymphatic system disorders Leukocytosis	5.0% 13/260 • Number of events 13 • Throughout 90 days post-procedure
Cardiac disorders Atrial fibrillation	7.7% 20/260 • Number of events 20 • Throughout 90 days post-procedure
Gastrointestinal disorders Dysphagia	3.5% 9/260 • Number of events 9 • Throughout 90 days post-procedure
Gastrointestinal disorders Nausea	3.1% 8/260 • Number of events 8 • Throughout 90 days post-procedure
Infections and infestations Pneumonia	5.4% 14/260 • Number of events 14 • Throughout 90 days post-procedure
Infections and infestations Urinary tract infection	6.2% 16/260 • Number of events 16 • Throughout 90 days post-procedure
Blood and lymphatic system disorders Thrombocytopenia	2.3% 6/260 • Number of events 6 • Throughout 90 days post-procedure
Injury, poisoning and procedural complications Fall	2.7% 7/260 • Number of events 7 • Throughout 90 days post-procedure
Metabolism and nutrition disorders Hyperglycaemia	2.3% 6/260 • Number of events 6 • Throughout 90 days post-procedure
Metabolism and nutrition disorders Hypernatraemia	4.2% 11/260 • Number of events 11 • Throughout 90 days post-procedure
Metabolism and nutrition disorders Hypokalaemia	5.8% 15/260 • Number of events 15 • Throughout 90 days post-procedure
Metabolism and nutrition disorders Hypomagnesaemia	2.3% 6/260 • Number of events 6 • Throughout 90 days post-procedure
Metabolism and nutrition disorders Hypophosphataemia	2.3% 6/260 • Number of events 6 • Throughout 90 days post-procedure
Nervous system disorders Brain oedema	2.3% 6/260 • Number of events 6 • Throughout 90 days post-procedure
Nervous system disorders Cerebral haemorrhage	3.8% 10/260 • Number of events 10 • Throughout 90 days post-procedure
Nervous system disorders Cerebral microhaemorrhage	2.3% 6/260 • Number of events 6 • Throughout 90 days post-procedure
Nervous system disorders Cerebral vasoconstriction	2.7% 7/260 • Number of events 7 • Throughout 90 days post-procedure
Nervous system disorders Haemorrhage intracranial	5.4% 14/260 • Number of events 14 • Throughout 90 days post-procedure
Nervous system disorders Haemorrhagic transformation stroke	3.1% 8/260 • Number of events 8 • Throughout 90 days post-procedure
Nervous system disorders Headache	3.8% 10/260 • Number of events 10 • Throughout 90 days post-procedure
Nervous system disorders Seizure	2.3% 6/260 • Number of events 6 • Throughout 90 days post-procedure
Nervous system disorders Subarachnoid haemorrhage	3.1% 8/260 • Number of events 8 • Throughout 90 days post-procedure
Psychiatric disorders Agitation	3.1% 8/260 • Number of events 8 • Throughout 90 days post-procedure
Renal and urinary disorders Acute kidney injury	5.0% 13/260 • Number of events 13 • Throughout 90 days post-procedure
Renal and urinary disorders Urinary retention	5.8% 15/260 • Number of events 15 • Throughout 90 days post-procedure
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.3% 6/260 • Number of events 6 • Throughout 90 days post-procedure
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	4.2% 11/260 • Number of events 11 • Throughout 90 days post-procedure
Vascular disorders Hypertension	4.2% 11/260 • Number of events 11 • Throughout 90 days post-procedure
Vascular disorders Hypotension	4.2% 11/260 • Number of events 11 • Throughout 90 days post-procedure

Additional Information

Didem Aksoy, Senior Director of Clinical Affairs

Imperative Care

Phone: 650-644-8293

Email: daksoy@imperativecare.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place