Status:
COMPLETED
The Imperative Trial: Treatment of Acute Ischemic Stroke With the Zoom Reperfusion System
Lead Sponsor:
Imperative Care, Inc.
Conditions:
Ischemic Stroke
Acute Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2024
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT04129125
Start Date
October 1 2021
End Date
May 28 2024
Last Update
August 8 2025
Active Locations (28)
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1
Radiology of Huntsville
Huntsville, Alabama, United States, 35801
2
Carondelet Neurological Institute St. Joseph's Hospital
Tucson, Arizona, United States, 85711
3
University of Southern California
Los Angeles, California, United States, 90033
4
John Muir Health
Walnut Creek, California, United States, 94598