Treatment With Intent to Generate Endovascular Reperfusion

Inclusion Criteria:

1. New focal neurologic deficit consistent with being of acute cerebral ischemia origin.

2. Age 18-85 years old (inclusive).

3. Interventionalist estimates that treatment with the Tigertriever (first deployment in
target vessel) can be achieved within 8 hours of symptom onset.

4. Patient either: a) eligible for, and received, IV t-PA within 3 hours of symptom
onset, at the correct 0.9 mg/kg dose, or b) ineligible for IV t-PA.

5. NIH Stroke Scale score of 8-29.

6. No known significant pre-stroke disability (prestroke mRS 0 or 1).

7. Catheter angiographic confirmation of a large vessel occlusion in the intracranial
internal carotid artery, the M1 or M2 segments of the middle cerebral artery, the
intracranial vertebral artery, or the basilar artery that is accessible to
Tigertriever device.

8. For strokes in the anterior circulation, the following imaging criteria should also be
met:

1. MRI criterion: volume of diffusion restriction visually assessed ≤50 mL, OR

2. CT criterion: ASPECTS 6 to 10 on baseline NCCT or CTA-source images,

9. For strokes in the posterior circulation, the following imaging criterion should also
be met: pcASPECTS score 8 to 10 on baseline NCCT, CTA-source images, or DWI MRI.

10. Anticipated life expectancy of at least 6 months.

11. A signed informed consent by patient or a Legally Authorized Representative or
independent physician in case of oral consent.

Exclusion Criteria:

1. Subject already participating in another study of an investigational treatment device
or treatment.

2. Use of any other intra-arterial recanalization drug or device prior to the
Tigertriever (Tigertriever not as 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/uL.

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).

16. Females who are pregnant or breastfeeding.

17. Known current use of cocaine at time of treatment.

18. Prior recent stroke in the past 3 months.

19. Renal failure with serum creatinine >3.0 or Glomerular Filtration Rate (GFR) <30.

20. Known cerebral vasculitis.

21. Rapidly improving neurological status defined as improvement of greater than 8 points
on the NIHSS or improvement to NIHSS of < 6 prior to procedure

22. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories.

23. Ongoing seizure due to stroke.

24. Evidence of active systemic infection.

25. Known cancer with metastases.

26. Suspicion of aortic dissection, septic embolus, or bacterial endocarditis.

27. Evidence of dissection in the extra or intracranial cerebral arteries.

28. Occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or
anterior/posterior circulation).

29. Aneurysm in target vessel.