A Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the Route 92 Medical Reperfusion System (SUMMIT MAX)

Exclusion Criteria

• •1. Known pregnancy or breast feeding
• •2. In the Investigator's opinion, any known comorbidity (including COVID-19 positivity) that may complicate treatment or prevent improvement or follow-up
• •3. Known serious, advanced, or terminal illness with anticipated life expectancy \< 12 months
• •4. Known history of severe allergy to contrast medium
• •5. Known to have suffered a stroke in the past 90 days
• •6. Known connective tissue disorder affecting the arteries (e.g. Marfan syndrome, Ehlers-Danlos syndrome)
• •7. Any known previous cerebral hemorrhagic event
• •8. Any known pre-existing coagulation deficiency
• •9. Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \>3.0
• •10. Known baseline platelet count \<50,000/µL
• •11. Known baseline blood glucose of \<50 mg/dL or \>400 mg/dL
• •12. Known to be participating in another study involving an investigational device or drug
• •13. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.
• •14. Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh cerebral hemorrhage (the presence of microbleeds is allowed)
• •15. Baseline CT or MRI showing intracranial tumor (except small meningioma \<= 2cm) or significant mass effect with midline shift due to the tumor
• •16. Presumed septic thrombus, or suspicion of bacterial endocarditis
• •17. Inability to access the cerebral vasculature in the opinion of the neurointerventional team
• •18. Unlikely to be available for a 90-day follow-up (e.g. no fixed home address)
• •19. Evidence of arterial dissection in a vessel that must be traversed
• •20. Evidence of high-grade stenosis or occlusion (i.e., tandem occlusion) in a vessel that must be traversed
• •21. Known active or recent history of cocaine or methamphetamine abuse (within last 6 months)
• •22. Known history or presence of aneurysm or arteriovenous malformation (AVM) in the territory of the target lesion
• •23. For all patients, severe sustained hypertension with SBP \>200 and/or DBP \>120; for patients treated with a lytic, sustained hypertension despite treatment with SBP \>185 and/or DBP \>110
• •24. Treatment with heparin within 48 hours with a partial thromboplastic time more than two times the laboratory normal or treatment with any LMWH within 48 hours
• •25. Renal failure with serum creatinine \>3.0 or Glomerular Filtration Rate (GFR) \<30
• •26. Ongoing seizure due to stroke
• •27. Evidence of active systemic infection
• •28. Known cancer with metastases
• •29. Angiographic evidence of a dissection in the extracranial or intracranial cerebral arteries
• •30. Arterial stenosis requiring balloon angioplasty or stenting at the time of the procedure
• •31. Angiographic evidence of multiple cerebrovascular occlusions (e.g., bilateral anterior circulation, anterior/posterior circulation, tandem occlusions)
• •32. Angiographic evidence of known or suspected underlying intracranial vasculopathy or atherosclerotic lesions responsible for the target occlusion
• •33. Angiographic evidence or suspicion of aortic dissection
• •34. Angiographic evidence of an aneurysm or arteriovenous malformation (AVM) in the territory of the target lesion