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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
328
Thrombectomy
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
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
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
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
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Core Lab-adjudicated Reperfusion Success
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Radiology of Huntsville
Huntsville, Alabama, United States
Carondelet Neurological Institute St. Joseph's Hospital
Tucson, Arizona, United States
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Los Angeles, California, United States
John Muir Health
Walnut Creek, California, United States
Baptist Health
Jacksonville, Florida, United States
University of Miami / Jackson Memorial Hospital
Miami, Florida, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, United States
Tampa General Hospital / University of South Florida
Tampa, Florida, United States
Grady Memorial Hospital / Emory University
Atlanta, Georgia, United States
Ochsner Health
New Orleans, Louisiana, United States
...and 18 more locations
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
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
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
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
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
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
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
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
ITT Cohort: Rate of All-Cause Mortality
Rate of 90-day all-cause mortality
Time frame: 90 days post-procedure
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
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
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
ITT Cohort: Rate of Serious Adverse Events
All serious adverse events through 90 days post-procedure.
Time frame: 90 days post-procedure
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
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
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
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
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
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
FDA Clearance Cohort: Rate of All-Cause Mortality
Rate of 90-day all-cause mortality
Time frame: 90-days post-procedure
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
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
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
FDA Clearance Cohort: Rate of Serious Adverse Events
All serious adverse events through 90 days post-procedure.
Time frame: 90-days post-procedure
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
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
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
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
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
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
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
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
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
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
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