Acute Stroke, Ischemic Stroke
Conditions
Keywords
stroke, thrombectomy, Zoom, aspiration, reperfusion, mRS
Brief summary
The trial is designed to assess the safety and efficacy of using the Zoom Reperfusion System in subjects diagnosed with acute ischemic stroke and undergoing a thrombectomy procedure within 8 hours of last known well.
Detailed description
Each year 17 million people suffer stroke worldwide. According to the World Stroke Organization, stroke has become the second cause of death and disability worldwide. In the United States, every year, more than 795,000 people have a stroke. Given the large-scale challenges of curing stroke, prevention and treatments for stroke are much needed. Ischemic stroke is treatable in many patients if they have early access to viable treatments. This trial is a prospective, multicenter, open-label, single-arm trial designed to assess the potential treatment benefits of using the Imperative Care 0.088 Catheters in conjunction with the other devices in the Zoom Reperfusion System to restore blood flow in patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease. The Zoom Reperfusion System includes the Imperative Care 0.088 Catheters, the Zoom Reperfusion Catheters (0.035 to 0.071 Catheters), Zoom Aspiration Tubing, and Zoom Aspiration Pump. The trial will assess reperfusion success using the mTICI scores in the absence of any rescue therapy, reperfusion time, first-pass success, and functional independence including a quality-of-life assessment.
Interventions
DEVICEZoom Reperfusion System
Thrombectomy
Sponsors
Imperative Care, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Reperfusion will be graded by an independent core lab that is not an enrolling investigational site. Neurological Outcome Assessors (NIHSS assessment): Neurological outcome assessors who will perform post-procedure 24-hour NIHSS assessments are NIHSS certified team members not performing the thrombectomy procedure and with no financial conflict of interest with Imperative Care, Inc. Functional Outcome Assessors (mRS assessment): Functional outcome assessors who will perform post-procedure assessments are part of achieving unbiased study objectives. They will not have access to patient data.
Intervention model description
Prospective, multicenter, open-label with independent outcome assessments.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 and older 2. NIHSS \>=6 3. The operator feels that the stroke can be treated with endovascular thrombectomy approaches and the interventionalist estimates that groin puncture can be achieved within 8 hours from time last seen well 4. Pre-event mRS scale 0-1 5. Large vessel occlusion of the intracranial internal carotid artery (ICA), middle cerebral artery (MCA)-M1 or M2 segments, basilar, or vertebral arteries as evidenced by MRA or CTA 6. For strokes in anterior circulation, ASPECTS \>=6; For strokes in posterior circulation, pc-ASPECTS \>=8 7. Non-contrast CT/CTA or MRI/MRA for trial eligibility performed or repeated at treating stroke center or outside medical facility within 2 hours of treatment initiation 8. If indicated per American Heart Association clinical guidelines, thrombolytic therapy should be administered as soon as possible 9. Consenting requirements met according to local IRB or Ethics Committee
Exclusion criteria
1. Female known to be pregnant at time of admission 2. Patient has suffered a stroke in the past 3 months 3. Presence of an existing or pre-existing large territory infarction 4. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluation, e.g., dementia with prescribed anti-cholinesterase inhibitor 5. Known history of severe contrast allergy or absolute contraindication to iodinated contrast 6. Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic 7. Life expectancy of less than 6 months prior to stroke onset 8. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories 9. Subject participating in another clinical trial involving an investigational device or drug 10. Known cancer with metastases 11. Evidence of active systemic infection 12. Any known hemorrhagic or coagulation deficiency Imaging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ITT Cohort: Rate of Core Lab-adjudicated Reperfusion Success | Intraprocedural | 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. |
| ITT Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board | 24-hour post-procedure | Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board |
| FDA Clearance Cohort: Rate of Core Lab-adjudicated Reperfusion Success | Intraprocedural | 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. |
| FDA Clearance Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board | 24-hour post-procedure | Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board |
| FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Core Lab-adjudicated Reperfusion Success | Intraprocedural | 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. |
| FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board | 24-hour post-procedure | Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ITT Cohort: Rate of All-Cause Mortality | 90 days post-procedure | Rate of 90-day all-cause mortality |
| ITT Cohort: Rate of All Intracranial Hemorrhage (ICH) | 24-hour post-procedure | Independent core lab adjudicated rate of all ICH at 24-hour post-procedure |
| ITT Cohort: Rate of Embolization in New Territory (ENT) | 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 |
| ITT Cohort: Rate of Serious Adverse Device Effects (SADEs) | 90 days post-procedure | Independent Safety Board adjudicated device-related serious adverse device events within 90 days post-procedure |
| ITT Cohort: Rate of Serious Adverse Events | 90 days post-procedure | All serious adverse events through 90 days post-procedure. |
| FDA Clearance Cohort: Time to Achieve mTICI Score ≥ 2b | Intraprocedural | The time from groin puncture to mTICI (modified treatment in cerebral infarction) score ≥ 2b mTICI range: 0 to 3; higher score means better reperfusion |
| FDA Clearance Cohort: Rate of mTICI Score 3 Reperfusion | 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 outcome |
| FDA Clearance Cohort: Rate of First Pass Success | 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 outcome |
| FDA Clearance Cohort: Rate of mTICI Score 2c Reperfusion | Intraprocedural | 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 |
| FDA Clearance Cohort: Rate of Functional Independence | 90-days post-procedure | 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. |
| FDA Clearance Cohort: Quality of Life Assessment | 90-days post-procedure | 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. |
| FDA Clearance Cohort: Rate of All-Cause Mortality | 90-days post-procedure | Rate of 90-day all-cause mortality |
| FDA Clearance Cohort: Rate of All Intracranial Hemorrhage (ICH) | 24-hour post-procedure | Independent core lab adjudicated rate of all ICH at 24-hour post-procedure |
| ITT Cohort: Time to Achieve mTICI Score ≥ 2b | Intraprocedural | The time from groin puncture to mTICI (modified treatment in cerebral infarction) score ≥ 2b mTICI range: 0 to 3; higher score means better reperfusion |
| FDA Clearance Cohort: Rate of Serious Adverse Device Effects (SADEs) | 90-days post-procedure | Independent Safety Board adjudicated device-related serious adverse device events within 90 days post-procedure |
| FDA Clearance Cohort: Rate of Serious Adverse Events | 90-days post-procedure | All serious adverse events through 90 days post-procedure. |
| FDA Clearance Cohort for Distal ICA/M1 Occlusions: Time to Achieve mTICI Score ≥ 2b | 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 |
| FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of mTICI Score 3 Reperfusion | 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 |
| FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of All Intracranial Hemorrhage (ICH) | 24-hour post-procedure | Independent core lab adjudicated rate of all ICH at 24-hour post-procedure |
| FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of First Pass Success | 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 |
| FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of mTICI Score 2c Reperfusion | Intraprocedural | 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 |
| FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Functional Independence | 90-days post-procedure | 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. |
| FDA Clearance Cohort for Distal ICA/M1 Occlusions: Quality of Life Assessment | 90-days post-procedure | 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. |
| FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of All-Cause Mortality | 90-days post-procedure | Rate of 90-day all-cause mortality |
| FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Embolization in New Territory (ENT) | 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 |
| FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Serious Adverse Device Effects (SADEs) | 90-days post-procedure | Independent Safety Board adjudicated device-related serious adverse device events within 90 days post-procedure |
| FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Serious Adverse Events | 90-days post-procedure | All serious adverse events through 90 days post-procedure |
| FDA Clearance Cohort: Rate of Embolization in New Territory (ENT) | 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 |
| ITT Cohort: Rate of mTICI Score 3 Reperfusion | 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 |
| ITT Cohort: Rate of First Pass Success | 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 outcome |
| ITT Cohort: Rate of mTICI Score 2c Reperfusion | Intraprocedural | 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 |
| ITT Cohort: Rate of Functional Independence | 90-days post-procedure | 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 |
| ITT Cohort: Quality of Life Assessment | 90 days post-procedure | 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. |
Countries
United States
Participant flow
Recruitment details
Between October 2021 and March 2024, participants were recruited across 26 institutions in the United States.
Participants by arm
| Arm | Count |
|---|---|
| Zoom Reperfusion System Aspiration thrombectomy using Zoom Reperfusion System | 260 |
| Total | 260 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Participants did not meet eligibility criteria | 65 |
| Overall Study | Study device was not used | 3 |
Baseline characteristics
| Characteristic | Zoom Reperfusion System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 154 Participants |
| Age, Categorical Between 18 and 65 years | 106 Participants |
| Age, Continuous | 68 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 211 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 19 Participants |
| Region of Enrollment United States | 260 participants |
| Sex: Female, Male Female | 127 Participants |
| Sex: Female, Male Male | 133 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 33 / 260 |
| other Total, other adverse events | 165 / 260 |
| serious Total, serious adverse events | 95 / 260 |
Outcome results
Primary
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Core Lab-adjudicated Reperfusion Success
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.
Time frame: Intraprocedural
Population: FDA Clearance Cohort - Covariate Analysis for Distal ICA/M1 Occlusions. Procedural imaging was not available for one (1) participant.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Core Lab-adjudicated Reperfusion Success | 125 Participants |
Primary
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board
Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board
Time frame: 24-hour post-procedure
Population: FDA Clearance Cohort - Covariate Analysis for Distal ICA/M1 Occlusions; Based on available imaging and NIHSS.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 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 |
Primary
FDA Clearance Cohort: Rate of Core Lab-adjudicated Reperfusion Success
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.
Time frame: 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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort: Rate of Core Lab-adjudicated Reperfusion Success | 177 Participants |
Comparison: The FDA agreed performance goal for the primary efficacy endpoint was for the lower bound of the two-sided 95% CI to be \>69%p-value: 0.000195% CI: [78, 89]Fisher Exact
Primary
FDA Clearance Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board
Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board
Time frame: 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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board | 2 Participants |
Comparison: The FDA agreed performance goal for the primary safety endpoint was for the observed rate to be ≤6.0%95% CI: [0.1, 3.4]
Primary
ITT Cohort: Rate of Core Lab-adjudicated Reperfusion Success
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.
Time frame: Intraprocedural
Population: ITT Cohort: Post thrombectomy imaging available for core lab adjudication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | ITT Cohort: Rate of Core Lab-adjudicated Reperfusion Success | 216 Participants |
Comparison: The FDA agreed performance goal for the primary efficacy endpoint was for the lower bound of the two-sided 95% CI to be \>69%p-value: <0.000195% CI: [78, 88]Fisher Exact
Primary
ITT Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board
Rate of symptomatic intracranial hemorrhage (sICH), as independently adjudicated by the core lab and the independent safety board
Time frame: 24-hour post-procedure
Population: ITT Cohort: Post-thrombectomy imaging available for core lab and independent safety board adjudication
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | ITT Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board | 5 Participants |
Comparison: The FDA agreed performance goal for the primary safety endpoint was for the observed rate to be ≤6.0%95% CI: [0.6, 4.4]
Secondary
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Quality of Life Assessment
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.
Time frame: 90-days post-procedure
Population: FDA Clearance Cohort - Covariate Analysis for Distal ICA/M1 Occlusions in subjects completing SIS assesment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zoom Reperfusion System | 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 |
| 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 |
| Zoom Reperfusion System | FDA Clearance Cohort for Distal ICA/M1 Occlusions: Quality of Life Assessment | Strength | 69.4 score on a scale | Standard Deviation 28.4 |
| Zoom Reperfusion System | FDA Clearance Cohort for Distal ICA/M1 Occlusions: Quality of Life Assessment | Emotion | 78.6 score on a scale | Standard Deviation 17.6 |
| Zoom Reperfusion System | FDA Clearance Cohort for Distal ICA/M1 Occlusions: Quality of Life Assessment | Communication | 84.7 score on a scale | Standard Deviation 23.6 |
| Zoom Reperfusion System | 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 |
| Zoom Reperfusion System | FDA Clearance Cohort for Distal ICA/M1 Occlusions: Quality of Life Assessment | Mobility | 70 score on a scale | Standard Deviation 30 |
| Zoom Reperfusion System | FDA Clearance Cohort for Distal ICA/M1 Occlusions: Quality of Life Assessment | Hand Function | 66.4 score on a scale | Standard Deviation 36.9 |
| Zoom Reperfusion System | 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
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of All-Cause Mortality
Rate of 90-day all-cause mortality
Time frame: 90-days post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of All-Cause Mortality | 21 Participants |
Secondary
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of All Intracranial Hemorrhage (ICH)
Independent core lab adjudicated rate of all ICH at 24-hour post-procedure
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of All Intracranial Hemorrhage (ICH) | 29 Participants |
Secondary
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Embolization in New Territory (ENT)
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
Time frame: End of procedure to 24-hour post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Embolization in New Territory (ENT) | 2 Participants |
Secondary
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of First Pass Success
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
Time frame: Intraprocedural
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of First Pass Success | 87 Participants |
Secondary
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Functional Independence
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.
Time frame: 90-days post-procedure
Population: Subjects with completed mRS assessments.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Functional Independence | 67 Participants |
Secondary
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of mTICI Score 2c Reperfusion
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
Time frame: Intraprocedural
Population: Post thrombectomy imaging available for core lab adjudication
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of mTICI Score 2c Reperfusion | 84 Participants |
Secondary
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of mTICI Score 3 Reperfusion
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
Time frame: Intraprocedural
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of mTICI Score 3 Reperfusion | 46 Participants |
Secondary
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Serious Adverse Device Effects (SADEs)
Independent Safety Board adjudicated device-related serious adverse device events within 90 days post-procedure
Time frame: 90-days post-procedure
Population: FDA Clearance Cohort - Covariate Analysis for Distal ICA/M1 Occlusions
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Serious Adverse Device Effects (SADEs) | 3 Participants |
Secondary
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Serious Adverse Events
All serious adverse events through 90 days post-procedure
Time frame: 90-days post-procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Serious Adverse Events | 54 Participants |
Secondary
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Time to Achieve mTICI Score ≥ 2b
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
Time frame: Intraprocedural
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort for Distal ICA/M1 Occlusions: Time to Achieve mTICI Score ≥ 2b | 18 minutes |
Secondary
FDA Clearance Cohort: Quality of Life Assessment
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort: Quality of Life Assessment | Memory and Thinking | 79.8 score on a scale | Standard Deviation 22.6 |
| Zoom Reperfusion System | FDA Clearance Cohort: Quality of Life Assessment | Hand Function | 70.5 score on a scale | Standard Deviation 34.9 |
| Zoom Reperfusion System | FDA Clearance Cohort: Quality of Life Assessment | Communication | 85.7 score on a scale | Standard Deviation 21.7 |
| Zoom Reperfusion System | 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 |
| Zoom Reperfusion System | FDA Clearance Cohort: Quality of Life Assessment | Mobility | 73.8 score on a scale | Standard Deviation 28.4 |
| Zoom Reperfusion System | FDA Clearance Cohort: Quality of Life Assessment | Participation/Role Function | 70.8 score on a scale | Standard Deviation 29.9 |
| Zoom Reperfusion System | FDA Clearance Cohort: Quality of Life Assessment | Overall Recovery | 72.7 score on a scale | Standard Deviation 25.7 |
| Zoom Reperfusion System | FDA Clearance Cohort: Quality of Life Assessment | Strength | 72.4 score on a scale | Standard Deviation 27.3 |
| Zoom Reperfusion System | FDA Clearance Cohort: Quality of Life Assessment | Emotion | 79.2 score on a scale | Standard Deviation 18 |
Secondary
FDA Clearance Cohort: Rate of All-Cause Mortality
Rate of 90-day all-cause mortality
Time frame: 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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort: Rate of All-Cause Mortality | 26 Participants |
Comparison: The FDA agreed performance goal for the primary safety endpoint was for the observed rate to be ≤20.3%95% CI: [8.1, 17.2]
Secondary
FDA Clearance Cohort: Rate of All Intracranial Hemorrhage (ICH)
Independent core lab adjudicated rate of all ICH at 24-hour post-procedure
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort: Rate of All Intracranial Hemorrhage (ICH) | 42 Participants |
Secondary
FDA Clearance Cohort: Rate of Embolization in New Territory (ENT)
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
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort: Rate of Embolization in New Territory (ENT) | 2 Participants |
Secondary
FDA Clearance Cohort: Rate of First Pass Success
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
Time frame: 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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort: Rate of First Pass Success | 128 Participants |
Secondary
FDA Clearance Cohort: Rate of Functional Independence
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.
Time frame: 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).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort: Rate of Functional Independence | 110 Participants |
Secondary
FDA Clearance Cohort: Rate of mTICI Score 2c Reperfusion
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
Time frame: 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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort: Rate of mTICI Score 2c Reperfusion | 124 Participants |
Secondary
FDA Clearance Cohort: Rate of mTICI Score 3 Reperfusion
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
Time frame: 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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort: Rate of mTICI Score 3 Reperfusion | 65 Participants |
Secondary
FDA Clearance Cohort: Rate of Serious Adverse Device Effects (SADEs)
Independent Safety Board adjudicated device-related serious adverse device events within 90 days post-procedure
Time frame: 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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort: Rate of Serious Adverse Device Effects (SADEs) | 3 Participants |
Secondary
FDA Clearance Cohort: Rate of Serious Adverse Events
All serious adverse events through 90 days post-procedure.
Time frame: 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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort: Rate of Serious Adverse Events | 74 Participants |
Secondary
FDA Clearance Cohort: Time to Achieve mTICI Score ≥ 2b
The time from groin puncture to mTICI (modified treatment in cerebral infarction) score ≥ 2b mTICI range: 0 to 3; higher score means better reperfusion
Time frame: 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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort: Time to Achieve mTICI Score ≥ 2b | 19 minutes |
Secondary
ITT Cohort: Quality of Life Assessment
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.
Time frame: 90 days post-procedure
Population: ITT Cohort: Participants that completed the SIS Questionnaire
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zoom Reperfusion System | ITT Cohort: Quality of Life Assessment | Overall Recovery | 71.5 score on a scale | Standard Deviation 25.8 |
| Zoom Reperfusion System | ITT Cohort: Quality of Life Assessment | Strength | 71 score on a scale | Standard Deviation 27.9 |
| Zoom Reperfusion System | ITT Cohort: Quality of Life Assessment | Memory and Thinking | 79.9 score on a scale | Standard Deviation 21.9 |
| Zoom Reperfusion System | ITT Cohort: Quality of Life Assessment | Emotion | 78.9 score on a scale | Standard Deviation 17.9 |
| Zoom Reperfusion System | ITT Cohort: Quality of Life Assessment | Communication | 85 score on a scale | Standard Deviation 22.6 |
| Zoom Reperfusion System | 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 |
| Zoom Reperfusion System | ITT Cohort: Quality of Life Assessment | Mobility | 71.5 score on a scale | Standard Deviation 29.5 |
| Zoom Reperfusion System | ITT Cohort: Quality of Life Assessment | Hand Function | 68.9 score on a scale | Standard Deviation 36 |
| Zoom Reperfusion System | ITT Cohort: Quality of Life Assessment | Participation/Role Function | 70.1 score on a scale | Standard Deviation 29.7 |
Secondary
ITT Cohort: Rate of All-Cause Mortality
Rate of 90-day all-cause mortality
Time frame: 90 days post-procedure
Population: ITT Cohort
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | ITT Cohort: Rate of All-Cause Mortality | 33 Participants |
Comparison: The FDA agreed performance goal for the all-cause mortality endpoint was for the observed rate to be ≤20.3%95% CI: [8.5, 16.7]
Secondary
ITT Cohort: Rate of All Intracranial Hemorrhage (ICH)
Independent core lab adjudicated rate of all ICH at 24-hour post-procedure
Time frame: 24-hour post-procedure
Population: ITT Cohort: Post thrombectomy imaging available for core lab adjudication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | ITT Cohort: Rate of All Intracranial Hemorrhage (ICH) | 53 Participants |
Secondary
ITT Cohort: Rate of Embolization in New Territory (ENT)
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
Time frame: 24-hour post-procedure
Population: ITT Cohort: Subjects with completed ENT assessment forms
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | ITT Cohort: Rate of Embolization in New Territory (ENT) | 2 Participants |
Secondary
ITT Cohort: Rate of First Pass Success
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
Time frame: Intraprocedural
Population: ITT Cohort
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | ITT Cohort: Rate of First Pass Success | 148 Participants |
Secondary
ITT Cohort: Rate of Functional Independence
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
Time frame: 90-days post-procedure
Population: ITT Cohort: Subjects with completed mRS assessments
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | ITT Cohort: Rate of Functional Independence | 133 Participants |
Secondary
ITT Cohort: Rate of mTICI Score 2c Reperfusion
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
Time frame: Intraprocedural
Population: ITT Cohort: Post thrombectomy imaging available for core lab adjudication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | ITT Cohort: Rate of mTICI Score 2c Reperfusion | 147 Participants |
Secondary
ITT Cohort: Rate of mTICI Score 3 Reperfusion
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
Time frame: Intraprocedural
Population: ITT Cohort: Post thrombectomy imaging available for core lab adjudication
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | ITT Cohort: Rate of mTICI Score 3 Reperfusion | 78 Participants |
Secondary
ITT Cohort: Rate of Serious Adverse Device Effects (SADEs)
Independent Safety Board adjudicated device-related serious adverse device events within 90 days post-procedure
Time frame: 90 days post-procedure
Population: ITT Cohort
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | ITT Cohort: Rate of Serious Adverse Device Effects (SADEs) | 5 Participants |
Secondary
ITT Cohort: Rate of Serious Adverse Events
All serious adverse events through 90 days post-procedure.
Time frame: 90 days post-procedure
Population: ITT Cohort
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | ITT Cohort: Rate of Serious Adverse Events | 95 Participants |
Secondary
ITT Cohort: Time to Achieve mTICI Score ≥ 2b
The time from groin puncture to mTICI (modified treatment in cerebral infarction) score ≥ 2b mTICI range: 0 to 3; higher score means better reperfusion
Time frame: Intraprocedural
Population: ITT Cohort
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Zoom Reperfusion System | ITT Cohort: Time to Achieve mTICI Score ≥ 2b | 19 minutes |
Post Hoc
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of mTICI Score ≥2b After All Study Device Passes
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.
Time frame: Intraprocedural
Population: FDA Clearance Cohort - Covariate Analysis for Distal ICA/M1 Occlusions
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 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
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
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.
Time frame: Intraprocedural
Population: FDA Clearance Cohort - Covariate Analysis for Distal ICA/M1 Occlusions
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 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
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of mTICI Score ≥2b at the End of the Procedure
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
Time frame: Intraprocedural
Population: FDA Clearance Cohort - Covariate Analysis for Distal ICA/M1 Occlusions
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of mTICI Score ≥2b at the End of the Procedure | 135 Participants |
Post Hoc
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Rescue to Achieve mTICI Score ≥ 2b
Use of additional devices to achieve mTICI Score ≥ 2b mTICI range: 0 to 3; higher score means better reperfusion
Time frame: Intraprocedural
Population: Participants in whom mTICI Score ≥ 2b was achieved
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Rescue to Achieve mTICI Score ≥ 2b | 5 Participants |
Post Hoc
FDA Clearance Cohort: Rate of Rescue to Achieve mTICI Score ≥ 2b
Use of additional devices to achieve mTICI Score ≥ 2b
Time frame: Intraprocedural
Population: Participants in whom mTICI Score ≥ 2b was achieved
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | FDA Clearance Cohort: Rate of Rescue to Achieve mTICI Score ≥ 2b | 9 Participants |
Post Hoc
ITT Cohort: Rate of Rescue to Achieve mTICI Score ≥2b
Use of additional devices to achieve core lab adjudicated mTICI score ≥2b
Time frame: Intraprocedural
Population: Patients in whom mTICI score ≥2b was achieved
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Zoom Reperfusion System | ITT Cohort: Rate of Rescue to Achieve mTICI Score ≥2b | 13 Participants |