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NCT06289985NARecruiting

StrokeNet Thrombectomy Endovascular Platform

Medical University of South Carolina

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

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 arterial puncture within 2 hours from qualifying CTA/MRA or CTP/MRP imaging \*CT/MR and qualifying CTA/MRA or CTP/MRP should be repeated if more than 120 minutes have elapsed since the imaging and randomization has not been performed. The exception is for LVO Mild deficit/Low NIHSS 0-5 for which imaging would only need to be repeated if there has been significant improvement in the NIHSS prior to randomization. 5\. Has one of the following presentations: 1. LVO patients with mild deficits/low NIHSS (must have both): 1. Mild presenting neurologic deficits - NIHSS 0-5 (Must have some focal neurological deficit attributable to the target occlusion if NIHSS 0) 2. Complete occlusion of the intracranial Internal Carotid Artery (ICA) or M1 Middle Cerebral Artery (MCA) 2. Medium/Distal Vessel Occlusion: 1. Visualized complete occlusion or perfusion deficit (Tmax \> 4s) supportive of a cortical branch occlusion in one of the following vessels: i) Non-dominant/Co-dominant M2 (defined as serving \< 50% of entire overall MCA territory) ii) M3 2. If symptom onset is \> 6h, the core must be less than 50% of the territory supplied by the occluded vessel as evident by either: i) Hypodensity and loss of grey-white border on NCCT or ii)ADC \<620 mm2/s on diffusion MRI or rCBF\<30% on CTP 3. NIHSS \> =8 STEP EVT INDICATION EXPANSION DOMAIN EXCLUSION CRITERIA: 1. Clinical 1. Presumed septic embolus; suspicion of bacterial endocarditis 2. Seizure at stroke onset or between onset and enrollment 3. Known anaphylactic reaction to contrast material that precludes endovascular reperfusion therapy 4. Intracranial occlusion suspected to be chronic, based on history and/or imaging 5. Intracranial dissection, based on history and/or imaging 6. Cerebral vasculitis, based on history and/or imaging 7. Known pregnancy 8. Known pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations 9. Known serious, advanced, or terminal illness or life expectancy less than 6 months in the investigator judgment 10. Known or high suspicion for underlying intracranial atherosclerotic disease (ICAD) 2. Laboratory a. Known platelet count \<100,000/uL 3. Imaging 1. CT ASPECT score \<6 (MRI ASPECT score \<7) 2. Unfavorable vascular anatomy that limits access to the occluded artery precluding endovascular reperfusion therapy. 3. Acute occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation) 4. Tandem occlusions 5. Significant mass effect with midline shift (\>5mm) 6. Evidence of intra-cranial tumor (except small meningioma defined as (1) \<=3 cm, (2) asymptomatic) as confirmed on CT/MRI) 7. Evidence of acute intracranial hemorrhage

Interventions

DEVICE

Endovascular thrombectomy with any FDA-approved category POL or NRY device

OTHER

Medical Management

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Conditions

Ischemic Stroke

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