Combined Thrombectomy for Distal MediUm Vessel Occlusion StroKe

Inclusion Criteria:

1. Age ≥18 years (no upper age limit)

2. Acute ischemic stroke where patient is ineligible for or has failed* IV thrombolytictreatment and is ineligible for endovascular treatment under best guideline-basedcare due to absence of proximal arterial occlusion (e.g. intracranial ICA, MCA-M1and co-dominant or dominant M2** segments, and vertebrobasilar arteries).***

• IV thrombolytic treatment failure is defined by persistent disabling neurologicaldeficits beyond 60 minutes of completion of thrombolytic infusion in the presence ofimaging findings consistent with DMVO.

**Dominant M2 segment is defined is a division supplying >50% of the MCA territoryvs co-dominant supplying 50% of the MCA territory vs non-dominant supplying <50% ofthe MCA territory.

***No procedures or tests required by the protocol will delay fastest possibledelivery of thrombolytic therapy to potentially eligible subjects.

3. Evidence of a primary (e.g. not secondary to EVT of proximal vessel occlusion)distal medium vascular occlusion defined as occlusion of the non-dominant M2 segmentor M3 segment of the MCA, the ACA (A1, A2, or A3 segments), or the PCA (P1, P2 or P3segments) resulting in significant clinical deficits and expected to be treatable byendovascular thrombectomy. Regardless of vessel anatomic location, all vesseldiameters should be within 1.5mm -2.5mm. (refer to the device labeling forrecommended vessel diameters for each device model.)*

4. No significant pre-stroke functional disability (mRS ≤2)

5. Evidence of a disabling stroke defined as follows:

6. Baseline National Institutes of Health Stroke Scale (NIHSS) score >5 at thetime of randomization.

7. NIHSS 3-5 with disabling deficit including significant aphasia, neglect,hemianopsia, or hemiparesis/ loss of hand or leg function as established by thetreating team in context of the patient's life.

8. The presence of a Target Mismatch defined as:

9. Ischemic Core < 50cc (defined on NCCT/CTP* or DWI-MRI) *Visual or automatedly detected hypodensity on NCCT should be used to excludeor include patients if the investigator believes that their assessment is morereliable than the CTP volume in any particular case.

10. Mismatch Volume (TMax >6sec lesion - Core volume lesion) >10cc

11. Mismatch Ratio >1.4

12. Patient treatable within 12 hours of symptom onset. Symptoms onset is defined as thepoint in time the patient was last seen well (at baseline). Treatment start isdefined as the time of arterial puncture.

13. Informed consent obtained from patient or acceptable patient surrogate

Exclusion Criteria:

1. Any sign of intracranial hemorrhage on baseline CT/MR (SDH/SAH/ICH).

2. Rapidly improving symptoms, particularly if in the judgment of the managingclinician that the improvement is likely to result in the patient having no residualdisabling deficits and an NIHSS score of <5 at randomization.

3. Significant ischemic changes in a territory other than the occluded site that in theopinion of the investigator could reduce the benefit of endovascular treatment.

4. Contra indication to imaging with MR or CT with contrast agents.

5. Infarct core >1/3 occluded territory (MCA, ACA, or PCA) qualitatively or >50 mLquantitatively (determined by NCCT, CTP or DWI).

6. Any terminal illness such that patient would not be expected to survive more than 1year.

7. Recent past history or clinical presentation of ICH, subarachnoid hemorrhage (SAH),arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm other thanmeningioma.

8. Any imaging findings suggestive of futile recanalization in the judgment of thelocal investigator.

9. Premorbid disability (mRS ≥3).

10. Inability to initiate endovascular treatment within 12 hours of last seen well.

11. Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS.

12. Baseline blood glucose of <50 mg/dL (2.78 mmol) or >400 mg/dL (22.20 mmol).

13. Known history of hereditary or acquired hemorrhagic diathesis and/or platelet count <100,000/uL.

14. Known renal failure as defined as serum creatinine levels > 3.0 mg/dL.

15. Presumed septic embolus or suspicion of bacterial endocarditis.

16. Any other condition that, in the opinion of the investigator, precludes anendovascular procedure or poses a significant hazard to the subject if anendovascular procedure was performed.

17. History of drug or alcohol use or dependence that, in the opinion of the siteinvestigator, would interfere with adherence to study requirements.

18. Subjects with occlusions in multiple vascular territories (e.g., bilateral ormulti-territorial anterior circulation, or anterior/posterior circulation)

19. Subject participating in a study involving an investigational drug or device thatwould impact this study

20. Known pregnancy

21. Prisoner or incarceration

22. Known acute symptomatic COVID-19 infection