Distal Ischemic Stroke Treatment With Adjustable Low-profile Stentriever

Inclusion Criteria:

1. Age 18-85 years old.

2. Pre-stroke mRS ≤2.

3. Disabling presenting deficits that localize to the territory of the distal vesselocclusion. Disabling deficits are deficits that, if unchanged, would prevent thesubject from performing basic activities of daily living (i.e., bathing, ambulating,toileting, hygiene, and eating) or returning to work.

4. NIHSS 4-24, or NIHSS 2-24 for patients with aphasia and/or hemianopia.

5. Perfusion lesion (Tmax >4.0 seconds) volume ≥10 cc on CTP or MR PWI within theterritory of the anterior cerebral artery (ACA) segments, a non-dominant orco-dominant M2 middle cerebral artery (MCA) segment, an M3 MCA, or the posteriorcerebral artery (PCA) segments.

6. Occluded distal vessel diameter ≥1.5 mm as measured on CTA or MRA.

7. Ischemic core lesion (rCBF<30% on CTP or ADC <620 on MR DWI) in ≤50% of theperfusion lesion volume.

8. Study treatment can be initiated within 24 hours of last known well time (last knowntime without current stroke symptoms).

9. Signed informed consent by patient or legally authorized representative.

10. Subject is not eligible for intravenous thrombolysis within 3 hours from strokeonset per FDA label and American Heart Association/American Stroke Associationnational guidelines. (Note: administration of intravenous thrombolytics should notbe avoided or delayed in order to achieve participation in this study.)

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 vesselocclusion (LVO) thrombectomy procedure.

4. Excessive tortuosity or stenosis that is anticipated to prevent placement of themicrocatheter in the target vessel. Tortuosity or stenosis will be determined on CTAor 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 aninternational normalized ratio (INR) of more than 1.7.

15. Treatment with heparin within 48 hours with a partial thromboplastin time more thantwo 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 treatmentdevice or treatment.