Gravity Stent-Retriever System For Reperfusion Of Large Vessel Occlusion Stroke Trial

Exclusion Criteria

• •1. Subject already participating in another study of an investigational treatment device or treatment.
• •2. Use any other intra-arterial recanalization drug or device prior to the use of Supernova (Supernova is not the first-choice device).
• •3. Angiographically evident excessive arterial tortuosity precluding device access to the thrombus.
• •4. For all patients, severe sustained hypertension with SBP \>220 and/or DBP \>120; for patients treated with IV tPA, sustained hypertension despite treatment with SBP \>185 and/or DBP \> 110.
• •5. Glucose \< 50 mg/dl (2.78 mmol/L) or \> 400 mg/dl (22.20 mmol/L).
• •6. Known hemorrhagic diathesis.
• •7. Coagulation factor deficiency or oral anti-coagulant therapy with an international normalized ratio (INR) of more than 3.0.
• •8. Treatment with heparin within 48 h with a partial thromboplastin time more than two times the laboratory normal.
• •9. Patients who have received a direct thrombin inhibitor within the last 48 hours; must have a partial thromboplastin time (PTT) less than 1.5 times the normal to be eligible.
• •10. Platelet count of less than 50,000/ µL.
• •11. History of severe allergy to contrast medium, nickel, or Nitinol.
• •12. Intracranial hemorrhage.
• •13. Significant mass effect with midline shift.
• •14. Intracranial tumor (apart from small meningioma, ≤ 2 cm in diameter).
• •15. Stenosis or any occlusion in the deployment site or in a proximal vessel requiring treatment or preventing device access to the thrombus (for example, stenosis or occlusion in the cervical internal carotid artery or common carotid artery).
• •16. Presence of intracranial atherosclerotic disease requiring rescue therapy (for example, intracranial stenting).
• •17. Females who are pregnant or breastfeeding.
• •18. Known current use of narcotic drugs at the time of treatment.
• •19. Prior recent stroke in the past 3 months.
• •20. Renal failure with serum creatinine \>3.0 or Glomerular Filtration Rate (GFR) \<30.
• •21. Known cerebral vasculitis.
• •22. Rapidly improving neurological status defined as the improvement of greater than 8 points on the NIHSS or improvement to NIHSS of \< 6 prior to the procedure.
• •23. Clinical symptoms are suggestive of bilateral stroke or stroke in multiple territories.
• •24. Ongoing seizure due to stroke.
• •25. Evidence of active systemic infection.
• •26. Known cancer with metastases.
• •27. Suspicion of aortic dissection, septic embolus, or bacterial endocarditis.
• •28. Evidence of dissection in the extra or intracranial cerebral arteries.
• •29. Occlusions in multiple vascular territories (e.g., bilateral anterior circulation or anterior/posterior circulation).
• •30. Aneurysm in the target vessel.