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

Prior treatment

• Life expectancy of less than 6 months prior to stroke onset
• Subject participating in another clinical trial involving an investigational device or drug

Other illness

• Patient has suffered a stroke in the past 3 months
• 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 symptoms suggestive of bilateral stroke or stroke in multiple territories
• Known cancer with metastases
• Evidence of active systemic infection
• Evidence of intracranial hemorrhage on CT/MRI

Other

• Female known to be pregnant at time of admission
• Presence of an existing or pre-existing large territory infarction
• Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic
• Any known hemorrhagic or coagulation deficiency
  • Imaging Exclusion Criteria:
• 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

• 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