Pulse Endovascular ReperFUSION for Acute Ischemic Stroke

Inclusion Criteria:

1. The participant provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Institutional Review Board (IRB) or anacceptable patient surrogate.

2. The participant is ≥ 18 years old and less than 85 years old.

3. Patients with symptomatic large vessel occlusion (LVO) who undergo MT as part oftheir standard of care and have residual occlusion involving the anterior, middle orposterior cerebral arteries resulting in a eTICI score greater than 2b50 at the endof the procedure with three or less MT device passes.

4. Estimated delay to onset of rescue Pulse NanoMED MicroBead administration <9 hoursfrom symptom onset, defined as the point in time the patient was last known well (LKW).

5. Post-MT and has had thrombolytic therapy <9 hours prior to the proposed start timeof System therapy

6. No significant pre-stroke functional disability (modified Rankin scale 0-1)

7. Baseline NIHSS≥6

8. ASPECTS >6 on non-contrast CT (NCCT) scan if symptoms lasting <8 hours

9. CT-Perfusion (CTP) is optional, if performed, should demonstrate rCBF <30% lesionvolume ≤70 mL.

10. Imaging should be obtained within 75 minutes of the onset of mechanicalthrombectomy.

Exclusion Criteria:

1. NIHSS score on admission >25

2. Use of carotid artery stents during the endovascular procedure requiring dualantiplatelet therapy

3. Female who is pregnant or lactating or has a positive pregnancy test at the time ofadmission

4. Current participation in another investigational drug or device treatment study

5. Known allergy or sensitivity to iron

6. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency

7. Known coagulopathy, INR >1.7, or use of novel anticoagulants <12h from symptom onset

8. Known Platelets <100,000

9. Known Renal Failure as defined by a serum creatinine >3.0 mg/dl (or 265.2 μmol/l) orglomerular Filtration Rate [GFR] <30

10. Subject who requires hemodialysis or peritoneal dialysis or who has acontraindication to angiogram for whatever reason

11. Any hemorrhage on CT/MRI

12. Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRIscan is normal.

13. Suspicion of aortic dissection

14. Subject currently uses or has a recent history of illicit drug(s) or abuses alcohol.

15. History of life-threatening allergy (more than rash) to contrast medium

16. SBP >185mmHg or DBP >110mmHg refractory to treatment

17. Serious, advanced, terminal illness with anticipated life expectancy <6 months

18. Pre-existing neurological or psychiatric disease that would confound evaluation

19. Presumed vasculitis or septic embolization

20. Known sensitivity or allergy to contrast materials that cannot be previously treatedproperly

21. The subject takes Coumadin and its interruption could compromise their safety

22. Known allergy or contraindication to double antiplatelet treatment

23. Known hypersensitivity or contraindication to iron or polyethylene glycol-basedagents

24. Known contraindication to MRI (examples include, but are not known, implantablecardioverter-defibrillator, pacemaker, clip-on or spiral aneurysm, neurostimulator)

25. The physical geometry of the subject that prevents the placement of the magnet

26. The subject has signs or symptoms of systemic infection/sepsis (temperature of ≥38.0Celsius and/or white blood cell count of ≥12,000 cells/uL). If the subject has alocalized infection, such as cellulitis or osteomyelitis, or the infection isproperly treated and controlled, according to the discretion of the researcher, thepatient can enroll

27. Known or suspected cardiovascular condition that causes a secondary or tertiaryheart block, tachycardia-bradycardia syndrome, or symptomatic postural hypotensionrequiring medical intervention

28. Known or suspected symptomatic hemochromatosis or hemosiderosis

29. Known or suspected liver disease, such as hepatitis and/or cirrhosis

30. The subject has received iron replacement therapy or contrast for iron-based MRI inthe previous 30 days