STEP: LVO Mild Deficit/Low NIHSS Strata

Important links:

  1. In-person consent
  2. Remote Consent
  3. WebDCU: Enrollment and Randomization
  4. Enrollment and Randomization Instructions

24/7 randomization hotline for after-hour emergency issues: 1-866-450-2016

During business hours: Faria Khattak (984-221-0266 / khattak@musc.edu) or Caitlin Schaffner (843-792-6588 / schaffne@musc.edu)

Inclusion Criteria:

  1. Suspected diagnosis of acute ischemic stroke
  2. Likely causative intracranial large or medium vessel occlusion
  3. Age 18 or older
  4. Pre-stroke modified Rankin Scale 0-2
  5. Presentation to enrolling hospital within 24 hours of last known well/stroke onset
  6. Able to initiate arterial puncture within 2 hours from qualifying CTA/MRA or CTP/MRP imaging
    • Baseline imaging would only need to be repeated if there has been significant improvement in the NIHSS prior to randomization
  7. Mild presenting neurological deficits – NIHSS 0-5
    • If 0, must have some focal neurological deficit attributable to the target occlusion
  8. Complete occlusion of the intracranial ICA or M1 MCA

Exclusion Criteria:

  1. Proven contraindication to endovascular thrombectomy
  2. Prisoner or incarcertated
  3. Presumed septic embolus; suspicion of bacterial endocarditis
  4. Seizure at stroke onset or between onset and enrollment
  5. Known anaphylactic reaction to contrast material that precludes endovascular reperfusion therapy
  6. Intracranial occlusion suspected to be chronic, based on history and/or imaging
  7. Intracranial dissection, based on history and/or imaging
  8. Cerebral vasculitis, based on history and/or imaging
  9. Known pregnancy
  10. Known pre-existing medical, neurological, or psychiatric disease that would confound the neurological or function evaludations
  11. Known serious, advanced, or terminal illness or life expectancy less than 6 months in the investigator judgement
  12. Known or high suspicion for underlying intracranial atherosclerotic disease
  13. Known platelet count less than 100,000/uL
  14. CT ASPECT score less than 6 or MRI ASPECT score less than 7
  15. Unfavorable vascular anatomy that limits access to the occluded artery precluding endovascular reperfusion therapy
  16. Acute occlusions in multiple vascular territories
    • E.g., bilateral anterior circulation, or anterior/posterior circulation
  17. Tandem occlusion
  18. Significant mass effect with midline shift
    • Greater than 5mm
  19. Evidence of intraaxial tumor
    • Except small meningioma
  20. Evidence of acute intracranial hemorrhage