STEP: StrokeNet Thrombectomy Endovascular Platform
Medical University of South Carolina
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).
Description
The StrokeNet Thrombectomy Endovascular Platform (STEP) is conducted within NIH StrokeNet at 38 comprehensive stroke centers across the US. The primary goal is to optimize all aspects of care of acute ischemic stroke patients with a large or a medium vessel occlusion. The platform trial operates under an overarching Master Protocol in an inferentially integrated framework. The platform trial is designed to support the studies of three broad categories of therapeutics: expansion of endovascular treatment (EVT) indications, innovative EVT devices and concomitant medical therapies, and novel pre-…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 arter…
Interventions
- DeviceEndovascular thrombectomy with any FDA-approved category POL or NRY device
Endovascular thrombectomy with any FDA-approved category POL or NRY device - Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment (POL), and/or Catheter, Thrombus Retriever (NRY)
- OtherMedical Management
Medical Management (MM) may involve any combination of the following: intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol-lowering medications, and rehabilitative care.
Locations (41)
- University of Alabama HospitalBirmingham, Alabama
- UCSD Health La JollaLa Jolla, California
- Kaiser Permanente Los Angeles Medical CenterLos Angeles, California
- Ronald Reagan UCLA Medical CenterLos Angeles, California
- UCSD Medical Center - Hillcrest HospitalSan Diego, California
- Stanford University Medical CenterStanford, California