The Imperative Trial: Treatment of Acute Ischemic Stroke With the Zoom Reperfusion System
- Conditions
- Ischemic StrokeAcute Stroke
- Interventions
- Device: Zoom Reperfusion System
- 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
- 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
-
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
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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
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Evidence of intracranial tumor (except small meningioma defined as ≤ 3cm and asymptomatic) as confirmed on CT/MRI
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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
- Arm && Interventions
Group Intervention Description Zoom Reperfusion System Zoom Reperfusion System The subject will undergo the endovascular thrombectomy procedure under general anesthesia or conscious sedation. The Imperative Care .088" Catheter will be used to gain access to the vasculature and direct aspiration of the clot will be attempted where feasible. The Zoom Reperfusion System must be the initial and primary device used to remove thrombus.
- Primary Outcome Measures
Name Time Method Primary Efficacy Endpoint Intraprocedural Rate of reperfusion success, defined as achieving mTICI score ≥ 2b flow with the Zoom Reperfusion System (primary treatment modality) without using additional thrombectomy devices or rescue therapy.
Primary Safety Endpoint 24-hour post-procedure Rate of symptomatic intracranial hemorrhage (sICH), as confirmed by imaging
- Secondary Outcome Measures
Name Time Method Time to achieve mTICI score ≥ 2b Intraprocedural The time from groin puncture to mTICI score ≥ 2b flow
Serious adverse device effects (SADEs) 90 days post-procedure All SADEs
Quality of Life Assessment 90 days post-procedure Measured by Stroke Impact Scale (SIS) Questionnaire
Rate of mTICI score 3 reperfusion Intraprocedural The proportion of patients achieving mTICI score 3 flow
Functional Independence 90 days post-procedure The proportion of patients achieving Modified Rankin Scale (mRS) ≤2 using the primary treatment modality
Mortality 90 days post-procedure All-cause mortality
Intracranial hemorrhage (ICH) 24-hour post-procedure All ICH, as confirmed by imaging
Serious adverse events 90 days post-procedure All serious adverse events
First pass success Intraprocedural The proportion of patients where the mTICI score ≥ 2b reperfusion was accomplished with the first pass
Rate of mTICI score 2c reperfusion Intraprocedural The proportion of patients achieving mTICI score ≥ 2c flow
Embolization in new territory (ENT) Intraprocedural Emboli observed immediately after thrombectomy and in a previously unaffected territory
Trial Locations
- Locations (28)
Cooper University Health Care
🇺🇸Camden, New Jersey, United States
Tampa General Hospital / University of South Florida
🇺🇸Tampa, Florida, United States
Carondelet Neurological Institute St. Joseph's Hospital
🇺🇸Tucson, Arizona, United States
Radiology of Huntsville
🇺🇸Huntsville, Alabama, United States
Baptist Health
🇺🇸Jacksonville, Florida, United States
Prisma Health - Upstate
🇺🇸Greenville, South Carolina, United States
Valley Baptist Medical Center
🇺🇸Harlingen, Texas, United States
The State University of New York at Buffalo
🇺🇸Buffalo, New York, United States
Mount Sinai
🇺🇸New York, New York, United States
John Muir Health
🇺🇸Walnut Creek, California, United States
Ochsner Health
🇺🇸New Orleans, Louisiana, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Tallahassee Neurological Clinic
🇺🇸Tallahassee, Florida, United States
Grady Memorial Hospital / Emory University
🇺🇸Atlanta, Georgia, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
The Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Erlanger Health System: Tennessee Interventional and Imaging Associates
🇺🇸Chattanooga, Tennessee, United States
Baylor Scott and White Research Institute
🇺🇸Dallas, Texas, United States
University of Miami / Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Oklahoma University
🇺🇸Oklahoma City, Oklahoma, United States
The University of Texas Health Science Center at Houston // Memorial Hermann Health System
🇺🇸Houston, Texas, United States
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
University of Pennsylvania
🇺🇸Pittsburgh, Pennsylvania, United States
Semmes Murphey Foundation / Methodist University Hospital
🇺🇸Memphis, Tennessee, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States