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

Completed · Not applicable

Conditions studied: Ischemic Stroke, Acute Stroke

In brief

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.

Key facts

Study ID

NCT04129125

Run by

Imperative Care, Inc.

People needed

328

Starts

2021-10-01

Expected to finish

2024-05-28

Last updated by the study team

2025-08-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Spectrum Health — Grand Rapids, Michigan, United States
• Munson Medical Center — Traverse City, Michigan, United States
• Cooper University Health Care — Camden, New Jersey, United States
• The State University of New York at Buffalo — Buffalo, New York, United States
• Mount Sinai — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• Oklahoma University — Oklahoma City, Oklahoma, United States
• Lehigh Valley Hospital — Allentown, Pennsylvania, United States
• UPMC — Pittsburgh, Pennsylvania, United States
• University of Pennsylvania — Pittsburgh, Pennsylvania, United States
• Prisma Health - Upstate — Greenville, South Carolina, United States
• Erlanger Health System: Tennessee Interventional and Imaging Associates — Chattanooga, Tennessee, United States
• Semmes Murphey Foundation / Methodist University Hospital — Memphis, Tennessee, United States
• Baylor Scott and White Research Institute — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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