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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial Assignment
Intervention Model Description
Adaptive Bayesian Platform Trial evaluating multiple interventions in multiple domains.
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Endovascular Therapy (EVT) Indication Expansion Domain: Low NIHSS Strata 		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)
  • Device: Endovascular thrombectomy with any FDA-approved category POL or NRY device
    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)
    Other names:
    • EVT
    • Endovascular Recanalization Therapy
    • Endovascular Therapy
  • Other: Medical Management
    Medical Management (MM) may involve any combination of the following: intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol-lowering medications, and rehabilitative care.
Other
Endovascular Therapy (EVT) Indication Expansion Domain: Medium/Distal Occlusions Strata 		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 occlusion will be randomized to receive one of two strategies: - Endovascular Therapy (EVT) - Medical Management (MM)
  • Device: Endovascular thrombectomy with any FDA-approved category POL or NRY device
    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)
    Other names:
    • EVT
    • Endovascular Recanalization Therapy
    • Endovascular Therapy
  • Other: Medical Management
    Medical Management (MM) may involve any combination of the following: intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol-lowering medications, and rehabilitative care.

Recruiting Locations

University of Alabama Hospital
Birmingham 4049979, Alabama 4829764 35294

UCSD Health La Jolla
La Jolla 5363943, California 5332921 92093

Kaiser Permanente Los Angeles Medical Center
Los Angeles 5368361, California 5332921 90027

Ronald Reagan UCLA Medical Center
Los Angeles 5368361, California 5332921 90095

UCSD Medical Center - Hillcrest Hospital
San Diego 5391811, California 5332921 92103

Stanford University Medical Center
Stanford 5398563, California 5332921 94304

Hartford Hospital
Hartford 4835797, Connecticut 4831725 06106

Yale New Haven Hospital
New Haven 4839366, Connecticut 4831725 06511

Jackson Memorial Hospital
Miami 4164138, Florida 4155751 33136

Tampa General Hospital
Tampa 4174757, Florida 4155751 33606

Grady Memorial Hospital
Atlanta 4180439, Georgia 4197000 30303

University of Chicago Medical Center
Chicago 4887398, Illinois 4896861 60637

University of Iowa Hospitals & Clinics
Iowa City 4862034, Iowa 4862182 52242

Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02115

Boston Medical Center
Boston 4930956, Massachusetts 6254926 02118

M Health Fairview Southdale Hospital
Edina 5025264, Minnesota 5037779 55435

M Health Fairview University of Minnesota Medical Center
Minneapolis 5037649, Minnesota 5037779 55455

Barnes Jewish Hospital
St Louis 4407066, Missouri 4398678 63110

Cooper University Hospital
Camden 4501018, New Jersey 5101760 08103

NYU Langone Hospital
Brooklyn 5110302, New York 5128638 11220

Buffalo General Medical Center
Buffalo 5110629, New York 5128638 14203

The Mount Sinai Hospital
New York 5128581, New York 5128638 10029

Stony Brook University Hospital
Stony Brook 5139865, New York 5128638 11794

Montefiore Medical Center
The Bronx 5110266, New York 5128638 10467

Carolinas Medical Center
Charlotte 4460243, North Carolina 4482348 28207

Wake Forest Baptist Medical Center
Winston-Salem 4499612, North Carolina 4482348 27157

University of Cincinnati Medical Center
Cincinnati 4508722, Ohio 5165418 45267

UH Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106

Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195

OSU Wexner Medical Center
Columbus 4509177, Ohio 5165418 43210

Hospital of the University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104

UPMC Presbyterian Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15213

UPMC Mercy Hospital
Pittsburgh 5206379, Pennsylvania 6254927 15243

Rhode Island Hospital
Providence 5224151, Rhode Island 5224323 02903

Medical University of South Carolina University Hospital
Charleston 4574324, South Carolina 4597040 29425

Memorial Hermann Texas Medical Center
Houston 4699066, Texas 4736286 77030

Medical City Plano
Plano 4719457, Texas 4736286 75075

University of Texas Health Science Center
San Antonio 4726206, Texas 4736286 78229

University of Utah Healthcare
Salt Lake City 5780993, Utah 5549030 84132

UVA Medical Center
Charlottesville 4752031, Virginia 6254928 22903

Harborview Medical Center
Seattle 5809844, Washington 5815135 98104

More Details

Status
Recruiting
Sponsor
Medical University of South Carolina

Study Contact

Jordan Elm
843-876-1605
elmj@musc.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.