Safety and Effectiveness of Mechanical Thrombectomy Using the Anaconda ANA5 Device

Key Inclusion Criteria:

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

2. Baseline National Institutes of Health Stroke Scale (NIHSS) obtained prior toprocedure ≥ 8 points and ≤ 25 points.

3. Pre-ictal modified Rankin Score (mRS) score of 0,1 or 2.

4. Treatable within 24 hours of symptom onset, defined as point in time when thesubject was last observed to be asymptomatic; treatment start is defined by arterialpuncture time.

5. If indicated, thrombolytic therapy shall be initiated per the institution's usualcare and the most recent version of the AHA/ASA Guidelines. Subjects eligible for IVthrombolysis should receive it without delay.

6. Occlusion (eTICI ≤ 1 flow) of the terminal carotid artery, middle cerebral artery M1segment or, dominant or proximal M2 segment, indicated for mechanical thrombectomy,confirmed with conventional angiography or CTA/MRA.

Key Exclusion Criteria:

1. Subject was diagnosed with a stroke in the past year.

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

3. Severe, sustained uncontrolled hypertension refractory to treatment (systolic bloodpressure >185 mmHg or diastolic blood pressure >110 mmHg).

4. Known pregnancy and/or lactating female.

5. CT or MRI evidence of hemorrhage (the presence of microbleeds is allowed).

6. Significant mass effect with midline shift.

7. Evidence of intracranial tumor (except small meningioma).

8. History of preexisting stent proximal to or at the occlusion site that may precludesafe deployment or recovery of the stent retriever.

9. Vessel tortuosity too difficult to allow endovascular access of the intracranial ICAper investigator judgement. Indicators of vessel tortuosity include but are notlimited to the presence of carotid loops and type 3 aortic arches.

10. Evidence of tandem lesions, including complete occlusion, high grade stenosis orarterial dissection in the extracranial or internal carotid artery (ICA), requiringtreatment or preventing access to thrombus.

11. Subjects with known or suspected underlying intracranial atherosclerotic lesionsresponsible for the target occlusion.

12. Subjects with occlusions in multiple vascular territories (e.g., bilateral anteriorcirculation, or anterior/posterior circulation).

13. Anatomical or physiological restrictions (e.g., severe stenosis, vasospasm, hightortuosity, etc.) detected via angiogram likely to result in an inability toposition the guide catheter or to deploy the ANA or intermediate catheter in thetargeted ICA segment with acceptable vessel diameter as defined in the Instructionsfor Use.