StrokeNet Thrombectomy Endovascular Platform
Start Date
1/31/2025
Completion Date
1/31/2030
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Endovascular thrombectomy with any FDA-approved category POL or NRY device
Medical Management
Conditions
Locations
University of Alabama Hospital
Birmingham, Alabama 35294
United States
UCSD Health La Jolla
La Jolla, California 92093
United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027
United States
Ronald Reagan UCLA Medical Center
Los Angeles, California 90095
United States
UCSD Medical Center - Hillcrest Hospital
San Diego, California 92103
United States
Stanford University Medical Center
Stanford, California 94304
United States
Hartford Hospital
Hartford, Connecticut 06106
United States
Yale New Haven Hospital
New Haven, Connecticut 06511
United States
Jackson Memorial Hospital
Miami, Florida 33136
United States
Tampa General Hospital
Tampa, Florida 33606
United States
Grady Memorial Hospital
Atlanta, Georgia 30303
United States
University of Chicago Medical Center
Chicago, Illinois 60637
United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
Boston Medical Center
Boston, Massachusetts 02118
United States
M Health Fairview Southdale Hospital
Edina, Minnesota 55435
United States
M Health Fairview University of Minnesota Medical Center
Minneapolis, Minnesota 55455
United States
Barnes Jewish Hospital
St Louis, Missouri 63110
United States
Cooper University Hospital
Camden, New Jersey 08103
United States
NYU Langone Hospital
Brooklyn, New York 11220
United States
Buffalo General Medical Center
Buffalo, New York 14203
United States
The Mount Sinai Hospital
New York, New York 10029
United States
Stony Brook University Hospital
Stony Brook, New York 11794
United States
Montefiore Medical Center
The Bronx, New York 10467
United States
Carolinas Medical Center
Charlotte, North Carolina 28207
United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina 27157
United States
University of Cincinnati Medical Center
Cincinnati, Ohio 45267
United States
UH Cleveland Medical Center
Cleveland, Ohio 44106
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
OSU Wexner Medical Center
Columbus, Ohio 43210
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania 15213
United States
UPMC Mercy Hospital
Pittsburgh, Pennsylvania 15243
United States
Rhode Island Hospital
Providence, Rhode Island 02903
United States
Medical University of South Carolina University Hospital
Charleston, South Carolina 29425
United States
Memorial Hermann Texas Medical Center
Houston, Texas 77030
United States
Medical City Plano
Plano, Texas 75075
United States
University of Texas Health Science Center
San Antonio, Texas 78229
United States
University of Utah Healthcare
Salt Lake City, Utah 84132
United States
UVA Medical Center
Charlottesville, Virginia 22903
United States
Harborview Medical Center
Seattle, Washington 98104
United States