A Prospective, Multi-center, Open Label and Single Arm Clinical Investigation to Evaluate the Safety and Efficacy of Using the Zoom Reperfusion System in Thrombectomy Procedures to Treat Acute Ischemic Stroke Patients
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.
• 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