Analysis of Revascularization in Ischemic Stroke With EmboTrap

Inclusion Criteria:

1. The patient or the patient's legally authorized representative has signed and dated an
Informed Consent Form.

2. Aged between 18 years and 85 years (inclusive).

3. A new focal disabling neurologic deficit consistent with acute cerebral ischemia.

4. NIHSS score ≥8 and ≤25.

5. Pre-ictal mRS score of 0 or 1.

6. The interventionalist estimates that at least one deployment of the EmboTrap device
can be completed within 8 hours from the onset of symptoms.

7. Patients for whom IV-tPA is indicated and who are available for treatment, are treated
with IV-tPA.

8. IV-tPA, if used, was initiated within 3 hrs of stroke onset (onset time is defined as
the last time when the patient was witnessed to be at baseline), with investigator
verification that the subject has received/is receiving the correct IV t-PA dose for
the estimated weight.

9. Angiographic confirmation of an occlusion of an ICA (including T or L occlusions), M1
or M2 MCA, VA, or BA with mTICI flow of 0 - 1.

10. 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 CT or CTA-source images, or, volume of
significantly lowered CBV ≤50 mL.

11. The patient is indicated for neurothrombectomy treatment by the interventionalist and
it is confirmed by diagnostic angiography that the device will be able to reach the
target lesion proximally.

Exclusion Criteria:

1. Life expectancy likely less than 6 months.

2. Females who are pregnant or breastfeeding.

3. History of severe allergy to contrast medium.

4. Known nickel allergy at time of treatment.

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

6. Patient has suffered a stroke in the past 3 months.

7. The patient presents with an NIHSS score <8 or >25 or is physician assessed as being
in a clinically relevant uninterrupted coma.

8. Subject participating in another study involving an investigational device or drug.

9. Use of warfarin anticoagulation or any Novel Anticoagulant with International
Normalized Ratio (INR) >3.0.

10. Platelet count <50,000/μL.

11. Glucose <50 mg/dL.

12. Any known hemorrhagic or coagulation deficiency.

13. Unstable renal failure with serum creatinine >3.0 or Glomerular Filtration Rate (GFR)
<30.

14. 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.

15. All patients with severe hypertension on presentation (SBP> 220mmHg and/or
DBP>120mmHg). All patients, in whom intravenous therapy with blood pressure
medications is indicated, with hypertension that remains severe and sustained despite
intravenous therapy (SBP >185mmHg and/or DBP>110mmHg). .

16. Known cerebral vasculitis.

17. Rapidly improving neurological status.

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

19. Ongoing seizure due to stroke.

20. Evidence of active systemic infection.

21. Known cancer with metastases.

22. Computed tomography (CT) or Magnetic Resonance Imaging (MRI) evidence of recent/ fresh
hemorrhage on presentation.

23. Baseline computed tomography (CT) or MRI showing mass effect or intracranial tumor
(except small meningioma).

24. Suspicion of aortic dissection, presumed septic embolus, or suspicion of bacterial
endocarditis.

25. Stenosis, or any occlusion, in a proximal vessel that requires treatment or prevents
access to the site of occlusion.

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

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