Tests clot-removal procedures and medical care for ischemic stroke

Trial details

Who runs it

Medical University of South Carolina

Trial code

NCT06289985

Record updated

4 December 2025

Original description

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).Read full original descriptionShow less

STEP: 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).

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.

ClinicalTrials.gov NCT06289985