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

Not Applicable

Completed

Conditions: Ischemic Stroke
Acute Stroke

Registration Number: NCT04129125

Lead Sponsor: Imperative Care, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 328

Inclusion Criteria

Age 18 and older
NIHSS >=6
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
Pre-event mRS scale 0-1
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
For strokes in anterior circulation, ASPECTS >=6; For strokes in posterior circulation, pc-ASPECTS >=8
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
If indicated per American Heart Association clinical guidelines, thrombolytic therapy should be administered as soon as possible
Consenting requirements met according to local IRB or Ethics Committee

Exclusion Criteria

Female known to be pregnant at time of admission
Patient has suffered a stroke in the past 3 months
Presence of an existing or pre-existing large territory infarction
Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluation, e.g., dementia with prescribed anti-cholinesterase inhibitor
Known history of severe contrast allergy or absolute contraindication to iodinated contrast
Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic
Life expectancy of less than 6 months prior to stroke onset
Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories
Subject participating in another clinical trial involving an investigational device or drug
Known cancer with metastases
Evidence of active systemic infection
Any known hemorrhagic or coagulation deficiency

Imaging Exclusion Criteria:
Evidence of intracranial hemorrhage on CT/MRI
CTA or MRA evidence of carotid stenosis requiring treatment for intracranial access
Excessive vascular access tortuosity or target vessel size that will likely prevent endovascular access with the Imperative Care 0.088" ID Catheters
Intracranial stent implanted in the same vascular territory that would preclude the safe deployment/removal of the thrombectomy devices
Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior circulation/vertebrobasilar system) as confirmed on CTA/MRA, or clinical evidence of bilateral strokes or strokes in multiple territories as determined by the treating physician
Significant mass effect with midline shift as confirmed on CT/MRI
Evidence of intracranial tumor (except small meningioma defined as ≤ 3cm and asymptomatic) as confirmed on CT/MRI
Angiographic evidence of pre-existing arterial injury, e.g., carotid dissection, complete cervical carotid occlusion, or vasculitis

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
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
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
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 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 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 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

Trial Locations

Locations (28): Radiology of Huntsville
🇺🇸
Huntsville, Alabama, United States
Carondelet Neurological Institute St. Joseph's Hospital
🇺🇸
Tucson, Arizona, United States
University of Southern California
🇺🇸
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
Scroll for more (18 remaining)
Radiology of Huntsville
🇺🇸Huntsville, Alabama, United States