Number of randomized patients:

202

Number of recruiting sites:

35

check-mark-1292787_960_720 Key inclusion criteria (Protocol Version 2.0 approved in Spain)

  1. Informed consent as documented by signature
  2. Age ≥ 18 to < 86 years
  3. Acute ischemic stroke (AIS)
  4. NIHSS ≥ 8 and < 30
  5. Patient is eligible for IV t-PA
  6. Patient is eligible for endovascular therapy
  7. Randomization no later than 4 hours 15 minutes after stroke symptom onset and initiation of IV t-PA must be started within 4 hours 30 minutes of stroke symptoms onset
  8. Occlusion (TICI 0-1) of the intracranial internal carotid artery (ICA) , M1 segment of the middle cerebral artery (MCA), or both confirmed by CT or MR angiography, accessible for MT
  9. ASPECTS score greater ≥ 6

check-mark-1292787_960_720Key inclusion criteria (Protocol Version 3.0 approved in Austria, Canada, Germany, France, Finland and Switzerland)

  1. Informed consent as documented by signature
  2. Age ≥ 18
  3. Acute ischemic stroke (AIS)
  4. NIHSS ≥ 5 and <30 (deficits judged to be clearly disabling at presentation)
  5. Patient is eligible for IV t-PA
  6. Patient is eligible for endovascular therapy
  7. Randomization no later than 4 hours 15 minutes after stroke symptom onset and initiation of IV t-PA must be started within 4 hours 30 minutes of stroke symptoms onset
  8. Occlusion (TICI 0-1) of the intracranial internal carotid artery (ICA) , M1 segment of the middle cerebral artery (MCA), or both confirmed by CT or MR angiography, accessible for MT
  9. Core-infarct volume of Alberta Stroke Program Early CT Score (ASPECTS) greater than or equal to 4 (≥ 4) based on baseline CT or MR imaging (MRI) (a region has to have diffusion abnormality in 20% or more of its volume to be considered MR-ASPECTS positive)

ISO_7010_P001_svg Key exclusion criteria

  1. Acute intracranial hemorrhage
  2. Any contraindication for IV t-PA
  3. Pre-treatment with IV t-PA
  4. In-hospital stroke
  5. Pregnancy or lactating women
  6. Known (serious) sensitivity to radiographic contrast agents, nickel, titanium metals or their alloys
  7. Current participation in a clinical trial
  8. Renal insufficiency
  9. Life expectancy less than 90 days at baseline
  10. Known advanced dementia or significant pre-stroke disability (mRS score of ≥ 2)