A Clinical Investigation to Evaluate and Compare the Safety and Efficacy of Using ZOOM Reperfusion Catheters and Stent Retrievers in Thrombectomy Procedures to Treat Acute Ischemic Stroke Patients
A Clinical Investigation to Evaluate and Compare the Safety and Efficacy of Using ZOOM Reperfusion Catheters and Stent Retrievers in Thrombectomy Procedures to Treat Acute Ischemic Stroke Patients
Prospective, randomized, open label, with blinded assessment (PROBE) to compare the rate of
 good functional outcomes at 90 days (mRS=0-2) following thrombectomy within 24 hours of
 stroke onset with either the Imperative Care ZOOM Reperfusion Catheter or stent retrievers.
Prospective, randomized, open label, with blinded assessment (PROBE) to compare the rate of
 good functional outcomes at 90 days (mRS=0-2) following thrombectomy within 24 hours of
 stroke onset with either the Imperative Care ZOOM Reperfusion Catheter or stent retrievers.

 Follow-up visits will occur at 24 hours, 3-7 days or discharge, and 90 days post-procedure
 and will review patient's functional outcome, quality of life, and adverse events.
Inclusion Criteria:

 1. Age 18 and older

 2. NIHSS >=6

 3. The operator feels that the stroke can be treated with endovascular thrombectomy
 approaches and the interventionalist estimates that groin puncture can be achieved
 within 24 hours from the onset of symptoms

 4. Pre-event mRS score 0-1

 5. Large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery
 (MCA)-M1 segments as evidenced by MRA or CTA

 6. ASPECT >=6

 7. Less than 1/3 MCA territory involved, as evidenced by baseline CT or MRI

 8. If stroke onset is within 6-24 hours, perfusion imaging is required to demonstrate a
 small core infarct volume (≤50cc for patients under 80 years old and ≤20cc for
 patients 80 years or older).

 9. Non-contrast CT/CTA or MRI/MRA for trial eligibility performed or repeated at treating
 stroke center or outside medical facility within two hour of treatment initiation.

 10. If indicated, IV t-PA should be administered as soon as possible, but no later than 3
 hours from onset of stroke symptoms (onset time is defined as the last time when the
 patient was witnessed to be at baseline), with investigator verification that the
 subject has received or is receiving the correct IV t-PA dose for the estimated weight
 prior to randomization

 11. 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 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 or nickel.

 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

 Image Exclusion Criteria

 13. Evidence of intracranial hemorrhage on CT/MRI

 14. Core infarct lesion volume >50 cc

 15. CTA or MRA evidence of extracranial carotid stenosis requiring treatment for
 intracranial access

 16. Excessive vascular access tortuosity that will likely prevent endovascular access

 17. Intracranial stent implanted in the same vascular territory that would preclude the
 safe deployment/removal of the thrombectomy devices.

 18. 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

 19. Significant mass effect with midline shift as confirmed on CT/MRI

 20. Evidence of intracranial tumor (except small meningioma defined as ≤ 3cm and
 asymptomatic) as confirmed on CT/MRI