Overview
Currently, the vast majority of these patients do not receive immediate vessel imaging with either CT- or MR-angiography. However, acute ischemic stroke patients with low NIHSS who harbor a large vessel occlusion (LVO) later decline in 20-40% of cases, and/or have underappreciated impairments related to their relatively mild strokes. Similarly, LVO patients presenting with a transient ischemic attack (TIA) are under increased risk of clinical deterioration. Such patients with apparent good collateral circulation, and hence a substantial perfusion of the vascular territory of the occluded large artery, likely have the most to gain from endovascular revascularization. At the same time, this collateral perfusion may allow for more frequent recanalization, either spontaneously or by intravenous (IV) rtPA. Experience with immediate mechanical thrombectomy (iMT) in the LVO mild stroke target population is limited.
This study will test the hypothesis that patients presenting within 8 hours of onset with cerebral ischemia in the setting of proximal large vessel occlusions (LVO) and low baseline NIHSS scores (0-5) will have better 90-day clinical outcomes (mRS distribution) with immediate mechanical thrombectomy (iMT) compared to initial medical management (iMM).
Principal investigator
Eligibility criteria
Exclusion Criteria: 1. NIHSS ≥6 2. Any sign of intracranial hemorrhage on baseline CT/MR (SDH/SAH/ICH) 3. Any imaging findings suggestive of futile recanalization in the judgment of the local investigator 4. High degree of suspicion of intracranial arterial disease (ICAD), such as evidence of multifocal ICAD 5. Premorbid disability (mRS ≥3) 6. Inability to randomize within 8 hours of last known well 7. Seizures at stroke onset if it precludes obtaining an accurate baseline NIHSS 8. Baseline blood glucose of \<50 mg/dL (2.78 mmol) or \>400 mg/dL (22.20 mmol) 9. Known coagulation disorders as defined as platelet count \<100,000/uL 10. Known renal failure as defined as serum creatinine levels \> 3.0 mg/dL 11. Presumed septic embolus or suspicion of bacterial endocarditis 12. Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure was performed. 13. Participation in another investigational treatment study in the previous 30 days 14. Intubation and mechanical ventilation prior to study enrollment is medically indicated 15. History of drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements 16. Site investigator does not have equipoise towards the ideal treatment concept (thrombectomy vs. best medical management) 17. Known pregnancy 18. Prisoner or incarceration 19. Known acute symptomatic COVID-19 infection
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