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RecruitingNCT06289985

StrokeNet Thrombectomy Endovascular Platform

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Trial Parameters

ConditionIschemic Stroke
SponsorMedical University of South Carolina
Study TypeINTERVENTIONAL
PhaseN/A
Enrollment1,600
SexALL
Min Age18 Years
Max AgeN/A
Start Date2025-01-31
Completion2029-01-31
Interventions
Endovascular thrombectomy with any FDA-approved category POL or NRY deviceMedical Management

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Brief Summary

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).

Eligibility Criteria

STEP PLATFORM INCLUSION CRITERIA: 1. Suspected diagnosis acute ischemic stroke 2. Likely causative intracranial large or medium vessel occlusion STEP PLATFORM EXCLUSION CRITERIA: 1. Proven contraindication to endovascular thrombectomy 2. Prisoners/incarcerated DOMAIN-SPECIFIC ELIGIBILITY CRITERIA: Each domain may have additional eligibility criteria. STEP EVT INDICATION EXPANSION DOMAIN INCLUSION CRITERIA: 1\. 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 randomizatio

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