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).
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- and early-hospital technologies and systems of care. As new interventions are put forth, they will be added to the Master Protocol as a new Domain or part of an existing Domain. STEP utilizes a flexible Bayesian design with frequent adaptive analyses to assess whether a given intervention is superior, inferior, or equivalent either within a Domain or for specific populations within the Domain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,600
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)
Medical Management (MM) may involve any combination of the following: intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol-lowering medications, and rehabilitative care.
Global disability measured by Modified Rankin Score
The modified Rankin Score is a 7-outcome ordinal scale where 0 = No symptoms and 6= Dead. The analysis of the primary endpoint will be based on a utility weighting of the 7 outcomes, where 0 represents the worst possible health state and 1 represents the best possible state.
Time frame: 90-day
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Alabama Hospital
Birmingham, Alabama, United States
RECRUITINGUCSD Health La Jolla
La Jolla, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
RECRUITINGUCSD Medical Center - Hillcrest Hospital
San Diego, California, United States
RECRUITINGStanford University Medical Center
Stanford, California, United States
RECRUITINGHartford Hospital
Hartford, Connecticut, United States
RECRUITINGYale New Haven Hospital
New Haven, Connecticut, United States
RECRUITINGJackson Memorial Hospital
Miami, Florida, United States
RECRUITINGTampa General Hospital
Tampa, Florida, United States
RECRUITING...and 31 more locations