StrokeNet Thrombectomy Endovascular Platform (STEP)

STEP: StrokeNet Thrombectomy Endovascular Platform

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).

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: Endovascular thrombectomy with any FDA-approved category POL or NRY device; Other: Medical Management

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.

• Study Type: Interventional
• Enrollment (Estimated): 1600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jordan Elm; Phone Number: 843-876-1605; Email: elmj@musc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama Hospital
  • California
    • La Jolla, California, United States, 92093
      • Recruiting
      • UCSD Health La Jolla
    • Los Angeles, California, United States, 90027
      • Recruiting
      • Kaiser Permanente Los Angeles Medical Center
    • Los Angeles, California, United States, 90095
      • Recruiting
      • Ronald Reagan UCLA Medical Center
    • San Diego, California, United States, 92103
      • Recruiting
      • UCSD Medical Center - Hillcrest Hospital
    • Stanford, California, United States, 94304
      • Recruiting
      • Stanford University Medical Center
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Recruiting
      • Hartford Hospital
    • New Haven, Connecticut, United States, 06511
      • Recruiting
      • Yale New Haven Hospital
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • Jackson Memorial Hospital
    • Tampa, Florida, United States, 33606
      • Recruiting
      • Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Recruiting
      • Grady Memorial Hospital
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago Medical Center
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa Hospitals & Clinics
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Boston Medical Center
      • Contact: Steven Feske, MD; Phone Number: 617-638-5350; Email: sfeske@bu.edu
      • Principal Investigator: Steven Feske, MD
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Recruiting
      • M Health Fairview Southdale Hospital
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • M Health Fairview University of Minnesota Medical Center
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Barnes Jewish Hospital
  • New Jersey
    • Camden, New Jersey, United States, 08103
      • Recruiting
      • Cooper University Hospital
  • New York
    • Brooklyn, New York, United States, 11220
      • Recruiting
      • NYU Langone Hospital
    • Buffalo, New York, United States, 14203
      • Recruiting
      • Buffalo General Medical Center
    • New York, New York, United States, 10029
      • Recruiting
      • The Mount Sinai Hospital
    • Stony Brook, New York, United States, 11794
      • Recruiting
      • Stony Brook University Hospital
      • Principal Investigator: David Fiorella, MD
      • Contact: Dawn Madigan; Phone Number: 631-444-8121; Email: Dawn.Madigan@stonybrookmedicine.edu
    • The Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Recruiting
      • Carolinas Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest Baptist Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Recruiting
      • University of Cincinnati Medical Center
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • UH Cleveland Medical Center
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • OSU Wexner Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Hospital of the University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • UPMC Presbyterian Hospital
    • Pittsburgh, Pennsylvania, United States, 15243
      • Recruiting
      • UPMC Mercy Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Recruiting
      • Rhode Island Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina University Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Memorial Hermann Texas Medical Center
    • Plano, Texas, United States, 75075
      • Recruiting
      • Medical City Plano
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • University of Texas Health Science Center
  • Utah
    • Salt Lake City, Utah, United States, 84132
      • Recruiting
      • University of Utah Healthcare
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • UVA Medical Center
  • Washington
    • Seattle, Washington, United States, 98104
      • Recruiting
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Endovascular Therapy; EVT; Endovascular Recanalization 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: Endovascular Therapy; EVT; Endovascular Recanalization 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global disability measured by Modified Rankin Score	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.	90-day

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global disability measured by Modified Rankin Score	The modified Rankin Score is a 7-outcome ordinal scale where 0 = No symptoms and 6= Dead.	1 day of hospital discharge
Neurological deficit as measured by the National Institutes of Health Stroke Scale (NIHSS)	NIHSS is a stroke severity score that ranges from 0 to 42, with higher numbers indicating a more severe stroke.	24 (+/-12) hours after the time of randomization
Symptomatic intracranial hemorrhage	modified Heidelberg definition	36 hours after randomization
Any radiologic intracranial hemorrhage	any acute intracranial blood, symptomatic or asymptomatic	36 hours after randomization
Mortality	all cause deaths	90 days

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: University of California, Los Angeles; National Institute of Neurological Disorders and Stroke (NINDS); Stony Brook University; University at Buffalo; University of Virginia; University of Cincinnati; MOUNT SINAI HOSPITAL; The Cooper Health System; Berry Consultants; University of Pittsburgh Medical Center
• Investigators: Principal Investigator: Pooja Khatri, MD, University of Cincinnati; Principal Investigator: Adnan Siddiqui, MD, PhD, University at Buffalo; Principal Investigator: Jordan J Elm, PhD, Medical University of South Carolina; Principal Investigator: Eva A Mistry, MBBS, MSCI, University of Cincinnati; Principal Investigator: Colin P Derdeyn, MD, University of Virginia; Principal Investigator: Jeffery L Saver, MD, University of California, Los Angeles; Principal Investigator: Tudor G Jovin, MD, The Cooper Health System; Principal Investigator: Raul G Nogueira, MD, FAHA, University of Pittsburgh; Principal Investigator: David Fiorella, MD, PhD, Stony Brook University; Principal Investigator: J Mocco, MD, MS, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2030

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Ischemic Stroke; Professional Practice; Organization and Administration; Health Services Administration; Practice Management; Practice Management, Medical
• Other Study ID Numbers: STEP; 1OT2NS129366-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant-level case report form data will be made available for research purposes upon completion of the trial. Low incidence values and free text fields will be collapsed or removed to ensure participant confidentiality.
• IPD Sharing Time Frame: One year after study is completed.
• IPD Sharing Access Criteria: NIH/NINDS website
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No