StrokeNet Thrombectomy Endovascular Platform
- Conditions
- Ischemic Stroke
- Registration Number
- NCT06289985
- Lead Sponsor
- Medical University of South Carolina
- 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).
- Detailed 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- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1600
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Global disability measured by Modified Rankin Score 90-day 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (41)
University of Alabama Hospital
🇺🇸Birmingham, Alabama, United States
UCSD Health La Jolla
🇺🇸La Jolla, California, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸Los Angeles, California, United States
Ronald Reagan UCLA Medical Center
🇺🇸Los Angeles, California, United States
UCSD Medical Center - Hillcrest Hospital
🇺🇸San Diego, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Scroll for more (31 remaining)University of Alabama Hospital🇺🇸Birmingham, Alabama, United States