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

Exclusion Criteria

• •1. Female known to be pregnant at time of admission
• •2. Patient has suffered a stroke in the past 3 months
• •3. Presence of an existing or pre-existing large territory infarction
• •4. Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluation, e.g., dementia with prescribed anti-cholinesterase inhibitor
• •5. Known history of severe contrast allergy or absolute contraindication to iodinated contrast
• •6. Clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic
• •7. Life expectancy of less than 6 months prior to stroke onset
• •8. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories
• •9. Subject participating in another clinical trial involving an investigational device or drug
• •10. Known cancer with metastases
• •11. Evidence of active systemic infection
• •12. Any known hemorrhagic or coagulation deficiency
• •13. Evidence of intracranial hemorrhage on CT/MRI
• •14. CTA or MRA evidence of carotid stenosis requiring treatment for intracranial access
• •15. Excessive vascular access tortuosity or target vessel size that will likely prevent endovascular access with the Imperative Care 0.088" ID Catheters
• •16. Intracranial stent implanted in the same vascular territory that would preclude the safe deployment/removal of the thrombectomy devices
• •17. 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
• •18. Significant mass effect with midline shift as confirmed on CT/MRI
• •19. Evidence of intracranial tumor (except small meningioma defined as ≤ 3cm and asymptomatic) as confirmed on CT/MRI
• •20. Angiographic evidence of pre-existing arterial injury, e.g., carotid dissection, complete cervical carotid occlusion, or vasculitis