StrokeNet Thrombectomy Endovascular Platform
- Conditions
- Ischemic Stroke
- Interventions
- Device: Endovascular thrombectomy with any FDA-approved category POL or NRY deviceOther: Medical Management
- 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
- 2000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Endovascular Therapy (EVT) Indication Expansion Domain: Medium/Distal Occlusions Strata Medical Management Adult patients with acute cerebral ischemia within 24 hours of last known who have Medium Vessel Occlusion (MVO) with Non-dominant/Co-dominant M2 occlusion or Distal Medium Vessel Occlusion (DMVO) patients with M3,4 or A1,2,3 or P1,2,3 occlusion will be randomized to receive one of two strategies: * Endovascular Therapy (EVT) * Medical Management (MM) Endovascular Therapy (EVT) Indication Expansion Domain: Low NIHSS Strata Medical Management Adult patients with acute cerebral ischemia within 24 hours of last known well who have large vessel occlusion (LVO) and mild deficits/low NIHSS (NIHSS 0-5) will be randomized to receive one of two strategies: * Endovascular Therapy (EVT) * Medical Management (MM) Endovascular Therapy (EVT) Indication Expansion Domain: Low NIHSS Strata Endovascular thrombectomy with any FDA-approved category POL or NRY device Adult patients with acute cerebral ischemia within 24 hours of last known well who have large vessel occlusion (LVO) and mild deficits/low NIHSS (NIHSS 0-5) will be randomized to receive one of two strategies: * Endovascular Therapy (EVT) * Medical Management (MM) Endovascular Therapy (EVT) Indication Expansion Domain: Medium/Distal Occlusions Strata Endovascular thrombectomy with any FDA-approved category POL or NRY device Adult patients with acute cerebral ischemia within 24 hours of last known who have Medium Vessel Occlusion (MVO) with Non-dominant/Co-dominant M2 occlusion or Distal Medium Vessel Occlusion (DMVO) patients with M3,4 or A1,2,3 or P1,2,3 occlusion will be randomized to receive one of two strategies: * Endovascular Therapy (EVT) * Medical Management (MM)
- 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
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Grady Memorial Hospital
🇺🇸Atlanta, Georgia, United States
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
University of Iowa Hospitals & Clinics
🇺🇸Iowa City, Iowa, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
M Health Fairview Southdale Hospital
🇺🇸Edina, Minnesota, United States
M Health Fairview University of Minnesota Medical Center
🇺🇸Minneapolis, Minnesota, United States
Barnes Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Cooper University Hospital
🇺🇸Camden, New Jersey, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States
NYU Langone Hospital
🇺🇸Brooklyn, New York, United States
Buffalo General Medical Center
🇺🇸Buffalo, New York, United States
The Mount Sinai Hospital
🇺🇸New York, New York, United States
Stony Brook University Hospital
🇺🇸Stony Brook, New York, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
UH Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
UPMC Presbyterian Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
OSU Wexner Medical Center
🇺🇸Columbus, Ohio, United States
UPMC Mercy Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States
Medical University of South Carolina University Hospital
🇺🇸Charleston, South Carolina, United States
Memorial Hermann Texas Medical Center
🇺🇸Houston, Texas, United States
Medical City Plano
🇺🇸Plano, Texas, United States
University of Texas Health Science Center
🇺🇸San Antonio, Texas, United States
University of Utah Healthcare
🇺🇸Salt Lake City, Utah, United States
UVA Medical Center
🇺🇸Charlottesville, Virginia, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States