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

Inclusion Criteria:

1. Age 18 and older

2. NIHSS >=6

3. The operator feels that the stroke can be treated with endovascular thrombectomyapproaches and the interventionalist estimates that groin puncture can be achievedwithin 8 hours from time last seen well

4. Pre-event mRS scale 0-1

5. Large vessel occlusion of the intracranial internal carotid artery (ICA), middlecerebral artery (MCA)-M1 or M2 segments, basilar, or vertebral arteries as evidencedby MRA or CTA

6. For strokes in anterior circulation, ASPECTS >=6; For strokes in posteriorcirculation, pc-ASPECTS >=8

7. Non-contrast CT/CTA or MRI/MRA for trial eligibility performed or repeated attreating stroke center or outside medical facility within 2 hours of treatmentinitiation

8. If indicated per American Heart Association clinical guidelines, thrombolytictherapy should be administered as soon as possible

9. Consenting requirements met according to local IRB or Ethics Committee

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 theneurological or functional evaluation, e.g., dementia with prescribedanti-cholinesterase inhibitor

5. Known history of severe contrast allergy or absolute contraindication to iodinatedcontrast

6. Clinical history, past imaging or clinical judgement suggest that the intracranialocclusion 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 deviceor drug

10. Known cancer with metastases

11. Evidence of active systemic infection

12. Any known hemorrhagic or coagulation deficiency Imaging Exclusion Criteria:

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 preventendovascular access with the Imperative Care 0.088" ID Catheters

16. Intracranial stent implanted in the same vascular territory that would preclude thesafe 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 clinicalevidence of bilateral strokes or strokes in multiple territories as determined bythe 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 andasymptomatic) as confirmed on CT/MRI

20. Angiographic evidence of pre-existing arterial injury, e.g., carotid dissection,complete cervical carotid occlusion, or vasculitis