StrokeNet Thrombectomy Endovascular Platform
STEP is a Randomized, Multifactorial, Adaptive Platform trial that seeks to optimize the care of patients with acute ischemic stroke (AIS) due to large (LVO) or medium vessel occlusions (MVO).
- EligibilityCriteria: 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 Pre-stroke modified Rankin Scale score 0-2 Within 24 hours of last known well  Has one of the following presentations:  a. Low NIHSS Patient (must have both): i.) Mild presenting neurologic deficits - NIHSS 0-5 ii.) Occlusion of the intracranial Internal Carotid Artery (ICA) or M1 Middle Cerebral Artery (MCA)  b. Medium/Distal Vessel Occlusion (must have all 3): i.) Lumen diameter >/= 0.75 ii.) Non-dominant/Co-dominant M2 or M3,4 or A1,2,3 or P1,2,3 iii.) Less than 50% core in the territory supplied by the occluded vessel as evident by hypodensity and loss of grey-white border on Non-contrast Computed Tomography (NCCT) or ADC <620 mm2/s on diffusion MRI or rCBF<30% on Computed Tomography Perfusion (CTP) after 6h of symptom onset.  STEP EVT INDICATION EXPANSION DOMAIN EXCLUSION CRITERIA:  Clinical  Presumed septic embolus; suspicion of bacterial endocarditis Seizure at stroke onset or between onset and enrollment Allergy 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  Laboratory  a. Known platelet count <100.000 uL  Imaging  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) Significant mass effect with midline shift (>5mm) Evidence of intraaxial tumor (except small meningioma) Evidence of acute intracranial hemorrhage - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult