StrokeNet Thrombectomy Endovascular Platform

A regiszterben nem jelölt feltételek

• STEP PLATFORM INCLUSION CRITERIA:
• Suspected diagnosis acute ischemic stroke
• Likely causative intracranial large or medium vessel occlusion
  • STEP PLATFORM EXCLUSION CRITERIA:
• Proven contraindication to endovascular thrombectomy
• Prisoners/incarcerated
  • DOMAIN-SPECIFIC ELIGIBILITY CRITERIA:
  • Each domain may have additional eligibility criteria.
  • STEP EVT INDICATION EXPANSION DOMAIN INCLUSION CRITERIA:
• Age 18 years or older 2. Pre-stroke modified Rankin Scale score 0-2 3. Presentation to enrolling hospital within 24 hours of last known well/stroke onset 4. Able to initiate arterial puncture within 2 hours from qualifying CTA/MRA or CTP/MRP imaging
  • *CT/MR and qualifying CTA/MRA or CTP/MRP should be repeated if more than 120 minutes have elapsed since the imaging and randomization has not been performed. The exception is for LVO Mild deficit/Low NIHSS 0-5 for which imaging would only need to be repeated if there has been significant improvement in the NIHSS prior to randomization.
• Has one of the following presentations:
• LVO patients with mild deficits/low NIHSS (must have both):
  • Mild presenting neurologic deficits - NIHSS 0-5 (Must have some focal neurological deficit attributable to the target occlusion if NIHSS 0)
  • Complete occlusion of the intracranial Internal Carotid Artery (ICA) or M1 Middle Cerebral Artery (MCA)
• Medium/Distal Vessel Occlusion:
  • Visualized complete occlusion or perfusion deficit (Tmax > 4s) supportive of a cortical branch occlusion in one of the following vessels:
  • Non-dominant/Co-dominant M2 (defined as serving < 50% of entire overall MCA territory) ii) M3
  • If symptom onset is > 6h, the core must be less than 50% of the territory supplied by the occluded vessel as evident by either:
  • Hypodensity and loss of grey-white border on NCCT or ii)ADC <620 mm2/s on diffusion MRI or rCBF<30% on CTP
  • NIHSS > =8
  • STEP EVT INDICATION EXPANSION DOMAIN EXCLUSION CRITERIA:
• Clinical
  • Presumed septic embolus; suspicion of bacterial endocarditis
  • Seizure at stroke onset or between onset and enrollment
  • Known anaphylactic reaction to contrast material that precludes endovascular reperfusion therapy
  • Intracranial occlusion suspected to be chronic, based on history and/or imaging
  • Intracranial dissection, based on history and/or imaging
  • Cerebral vasculitis, based on history and/or imaging
  • Known pregnancy
  • Known pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations
  • Known serious, advanced, or terminal illness or life expectancy less than 6 months in the investigator judgment
  • Known or high suspicion for underlying intracranial atherosclerotic disease (ICAD)
• Laboratory
  • Known platelet count <100,000/uL
• Imaging
  • CT ASPECT score <6 (MRI ASPECT score <7)
  • Unfavorable vascular anatomy that limits access to the occluded artery precluding endovascular reperfusion therapy.
  • Acute occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation)
  • Tandem occlusions
  • Significant mass effect with midline shift (>5mm)
  • Evidence of intra-cranial tumor (except small meningioma defined as (1) <=3 cm, (2) asymptomatic) as confirmed on CT/MRI)
  • Evidence of acute intracranial hemorrhage