Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06289985

StrokeNet Thrombectomy Endovascular Platform

Led by Medical University of South Carolina · Updated on 2025-12-04

1600

Participants Needed

41

Research Sites

260 weeks

Total Duration

On this page

Sponsors

M

Medical University of South Carolina

Lead Sponsor

N

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

StrokeNet Thrombectomy Endovascular Platform

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Suspected diagnosis of acute ischemic stroke
  • Likely cause is an intracranial large or medium vessel occlusion
  • Age 18 years or older
  • Pre-stroke modified Rankin Scale score between 0 and 2
  • Presentation to hospital within 24 hours of stroke onset or last known well time
  • Able to start arterial puncture within 2 hours of qualifying imaging (CTA/MRA or CTP/MRP)
  • For large vessel occlusion with mild deficits: NIHSS 0-5 with focal neurological deficit attributable to the occlusion
  • Complete occlusion of intracranial Internal Carotid Artery or M1 Middle Cerebral Artery
  • For medium/distal vessel occlusion: visualized complete occlusion or perfusion deficit in specific brain arteries
  • If symptom onset is more than 6 hours, core infarct must be less than 50% of the territory supplied by the occluded vessel on imaging
  • NIHSS score of 8 or higher for medium/distal vessel occlusion
Not Eligible

You will not qualify if you...

  • Proven contraindication to endovascular thrombectomy
  • Prisoners or incarcerated individuals
  • Presumed septic embolus or suspicion of bacterial endocarditis
  • Seizure at stroke onset or between onset and enrollment
  • Known anaphylactic reaction to contrast material precluding reperfusion therapy
  • Intracranial occlusion suspected to be chronic
  • Intracranial dissection
  • Cerebral vasculitis
  • Known pregnancy
  • Pre-existing medical, neurological, or psychiatric disease that may confound evaluations
  • Advanced or terminal illness with life expectancy under 6 months
  • Known or suspected intracranial atherosclerotic disease
  • Platelet count less than 100,000 per microliter
  • CT ASPECT score less than 6 or MRI ASPECT score less than 7
  • Unfavorable vascular anatomy preventing access to occluded artery
  • Acute occlusions in multiple vascular territories
  • Tandem occlusions
  • Significant brain swelling with midline shift over 5 mm
  • Evidence of intracranial tumor except small, asymptomatic meningioma 3 cm or smaller
  • Acute intracranial hemorrhage

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 41 locations

1

University of Alabama Hospital

Birmingham, Alabama, United States, 35294

Actively Recruiting

2

UCSD Health La Jolla

La Jolla, California, United States, 92093

Actively Recruiting

3

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States, 90027

Actively Recruiting

4

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States, 90095

Actively Recruiting

5

UCSD Medical Center - Hillcrest Hospital

San Diego, California, United States, 92103

Actively Recruiting

6

Stanford University Medical Center

Stanford, California, United States, 94304

Actively Recruiting

7

Hartford Hospital

Hartford, Connecticut, United States, 06106

Actively Recruiting

8

Yale New Haven Hospital

New Haven, Connecticut, United States, 06511

Actively Recruiting

9

Jackson Memorial Hospital

Miami, Florida, United States, 33136

Actively Recruiting

10

Tampa General Hospital

Tampa, Florida, United States, 33606

Actively Recruiting

11

Grady Memorial Hospital

Atlanta, Georgia, United States, 30303

Actively Recruiting

12

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

Actively Recruiting

13

University of Iowa Hospitals & Clinics

Iowa City, Iowa, United States, 52242

Actively Recruiting

14

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

15

Boston Medical Center

Boston, Massachusetts, United States, 02118

Actively Recruiting

16

M Health Fairview Southdale Hospital

Edina, Minnesota, United States, 55435

Actively Recruiting

17

M Health Fairview University of Minnesota Medical Center

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

18

Barnes Jewish Hospital

St Louis, Missouri, United States, 63110

Actively Recruiting

19

Cooper University Hospital

Camden, New Jersey, United States, 08103

Actively Recruiting

20

NYU Langone Hospital

Brooklyn, New York, United States, 11220

Actively Recruiting

21

Buffalo General Medical Center

Buffalo, New York, United States, 14203

Actively Recruiting

22

The Mount Sinai Hospital

New York, New York, United States, 10029

Actively Recruiting

23

Stony Brook University Hospital

Stony Brook, New York, United States, 11794

Actively Recruiting

24

Montefiore Medical Center

The Bronx, New York, United States, 10467

Actively Recruiting

25

Carolinas Medical Center

Charlotte, North Carolina, United States, 28207

Actively Recruiting

26

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

27

University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45267

Actively Recruiting

28

UH Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

29

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

30

OSU Wexner Medical Center

Columbus, Ohio, United States, 43210

Actively Recruiting

31

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

32

UPMC Presbyterian Hospital

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

33

UPMC Mercy Hospital

Pittsburgh, Pennsylvania, United States, 15243

Actively Recruiting

34

Rhode Island Hospital

Providence, Rhode Island, United States, 02903

Actively Recruiting

35

Medical University of South Carolina University Hospital

Charleston, South Carolina, United States, 29425

Actively Recruiting

36

Memorial Hermann Texas Medical Center

Houston, Texas, United States, 77030

Actively Recruiting

37

Medical City Plano

Plano, Texas, United States, 75075

Actively Recruiting

38

University of Texas Health Science Center

San Antonio, Texas, United States, 78229

Actively Recruiting

39

University of Utah Healthcare

Salt Lake City, Utah, United States, 84132

Actively Recruiting

40

UVA Medical Center

Charlottesville, Virginia, United States, 22903

Actively Recruiting

41

Harborview Medical Center

Seattle, Washington, United States, 98104

Actively Recruiting

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Research Team

J

Jordan Elm

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

2

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