Distal Ischemic Stroke Treatment With Adjustable Low-profile Stentriever

Exclusion Criteria

• •1. Evidence of acute brain hemorrhage on CT and/or MRI at admission.
• •2. Use of any other intra-arterial (IA) recanalization device prior to the Tigertriever 13 in the target vessel, including aspiration catheter.
• •3. The DVO is a secondary distal occlusion that occurred during a large vessel occlusion (LVO) thrombectomy procedure.
• •4. Excessive tortuosity or stenosis that is anticipated to prevent placement of the microcatheter in the target vessel. Tortuosity or stenosis will be determined on CTA or MRA prior to randomization.
• •5. Evidence of tandem occlusion in the cervical internal carotid artery (ICA), intracranial ICA, M1 MCA, dominant M2 MCA, vertebral artery (VA) or basilar artery (BA) on CTA or MRA.
• •6. Evidence of dissection in the extra or intracranial cerebral arteries.
• •7. Evidence of bilateral acute stroke or acute stroke in multiple territories (e.g., bilateral anterior circulation, anterior/posterior circulation).
• •8. Prior stroke in the last 3 months.
• •9. Anticipated inability to obtain 3-month follow-up assessments.
• •10. Females who are pregnant or breastfeeding.
• •11. Renal failure with serum creatinine \>3.0 or Glomerular Filtration Rate (GFR) \<30.
• •12. Pre-procedural severe sustained hypertension with SBP \>220 and/or DBP \>120.
• •13. Pre-procedural glucose \<50 mg/dl (2.78 mmol/L) or \>400 mg/dl (22.20 mmol/L).
• •14. Pre-procedural coagulation factor deficiency or oral anti-coagulant therapy with an international normalized ratio (INR) of more than 1.7.
• •15. Treatment with heparin within 48 hours with a partial thromboplastin time more than two times the laboratory normal.
• •16. Treatment with a direct oral anticoagulant (DOAC) within 48 hours.
• •17. Platelet count of less than 50,000/uL.
• •18. History of severe allergy to contrast medium, nickel, or Nitinol.
• •19. Known current use of cocaine at time of treatment.
• •20. Known or suspected cerebral vasculitis.
• •21. Known hemorrhagic diathesis.
• •22. Aneurysm in target vessel.
• •23. Intracranial tumor (apart from small meningioma, ≤2 cm in diameter).
• •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. Subject already participating in another study of an investigational treatment device or treatment.