The Imperative Trial: Treatment of Acute Ischemic Stroke With the Zoom Reperfusion System (NCT04129125) | Clinical Trial Compass
CompletedNot Applicable
The Imperative Trial: Treatment of Acute Ischemic Stroke With the Zoom Reperfusion System
United States328 participantsStarted 2021-10-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
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
What they're measuring
1
ITT Cohort: Rate of Core Lab-adjudicated Reperfusion Success
Timeframe: Intraprocedural
2
ITT Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board
Timeframe: 24-hour post-procedure
3
FDA Clearance Cohort: Rate of Core Lab-adjudicated Reperfusion Success
Timeframe: Intraprocedural
4
FDA Clearance Cohort: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board
Timeframe: 24-hour post-procedure
5
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Core Lab-adjudicated Reperfusion Success
Timeframe: Intraprocedural
6
FDA Clearance Cohort for Distal ICA/M1 Occlusions: Rate of Symptomatic Intracranial Hemorrhage (sICH), as Independently Adjudicated by Core Lab and Safety Board