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Ischemic StrokeSTEPNCT06289985

StrokeNet Thrombectomy Endovascular Platform

A study testing Endovascular thrombectomy with any FDA-approved category POL or NRY device and Medical Management in people with Ischemic Stroke, run by Medical University of South Carolina at 41 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ischemic Stroke
What is being tested?
Endovascular thrombectomy with any FDA-approved category POL or NRY device and Medical Management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,600 participants
Where
41 sitesUnited States
Study dates
31 Jan 2025to 31 Jan 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

  1. Has one of the following presentations:
  2. LVO patients with mild deficits/low NIHSS (must have both):
  3. Mild presenting neurologic deficits - NIHSS 0-5 (Must have some focal neurological deficit attributable to the target occlusion if NIHSS 0)
  4. Complete occlusion of the intracranial Internal Carotid Artery (ICA) or M1 Middle Cerebral Artery (MCA)
  5. Medium/Distal Vessel Occlusion:
  6. Visualized complete occlusion or perfusion deficit (Tmax > 4s) supportive of a cortical branch occlusion in one of the following vessels:
  7. Non-dominant/Co-dominant M2 (defined as serving < 50% of entire overall MCA territory) ii) M3
  8. If symptom onset is > 6h, the core must be less than 50% of the territory supplied by the occluded vessel as evident by either:
  9. Hypodensity and loss of grey-white border on NCCT or ii)ADC <620 mm2/s on diffusion MRI or rCBF<30% on CTP
  10. NIHSS > =8

STEP EVT INDICATION EXPANSION DOMAIN EXCLUSION CRITERIA:

  1. Clinical
  2. Presumed septic embolus; suspicion of bacterial endocarditis
  3. Seizure at stroke onset or between onset and enrollment
  4. Known anaphylactic reaction to contrast material that precludes endovascular reperfusion therapy
  5. Intracranial occlusion suspected to be chronic, based on history and/or imaging
  6. Intracranial dissection, based on history and/or imaging
  7. Cerebral vasculitis, based on history and/or imaging
  8. Known pregnancy
  9. Known pre-existing medical, neurological or psychiatric disease that would confound the neurological or functional evaluations
  10. Known serious, advanced, or terminal illness or life expectancy less than 6 months in the investigator judgment
  11. Known or high suspicion for underlying intracranial atherosclerotic disease (ICAD)
  12. Laboratory
  13. Known platelet count <100,000/uL
  14. Imaging
  15. CT ASPECT score <6 (MRI ASPECT score <7)
  16. Unfavorable vascular anatomy that limits access to the occluded artery precluding endovascular reperfusion therapy.
  17. Acute occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation)
  18. Tandem occlusions
  19. Significant mass effect with midline shift (>5mm)
  20. Evidence of intra-cranial tumor (except small meningioma defined as (1) <=3 cm, (2) asymptomatic) as confirmed on CT/MRI)
  21. Evidence of acute intracranial hemorrhage

Trial locations and contacts

41 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jordan Elm contact

843-876-1605

elmj@musc.edu

41 sites in 1 country

United States41 sites, 41 recruiting

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

    Recruiting

  • University of Alabama Hospital

    Birmingham, Alabama, 35294

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

    Recruiting

  • Boston Medical Center

    Boston, Massachusetts, 02118

    Recruiting

  • NYU Langone Hospital

    Brooklyn, New York, 11220

    Recruiting

  • Buffalo General Medical Center

    Buffalo, New York, 14203

    Recruiting

  • Cooper University Hospital

    Camden, New Jersey, 08103

    Recruiting

  • Medical University of South Carolina University Hospital

    Charleston, South Carolina, 29425

    Recruiting

  • Carolinas Medical Center

    Charlotte, North Carolina, 28207

    Recruiting

  • UVA Medical Center

    Charlottesville, Virginia, 22903

    Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Recruiting

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

    Recruiting

  • UH Cleveland Medical Center

    Cleveland, Ohio, 44106

    Recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Recruiting

  • OSU Wexner Medical Center

    Columbus, Ohio, 43210

    Recruiting

  • M Health Fairview Southdale Hospital

    Edina, Minnesota, 55435

    Recruiting

  • Hartford Hospital

    Hartford, Connecticut, 06106

    Recruiting

  • Memorial Hermann Texas Medical Center

    Houston, Texas, 77030

    Recruiting

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242

    Recruiting

  • UCSD Health La Jolla

    La Jolla, California, 92093

    Recruiting

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

    Recruiting

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

    Recruiting

  • Jackson Memorial Hospital

    Miami, Florida, 33136

    Recruiting

  • M Health Fairview University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455

    Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut, 06511

    Recruiting

  • The Mount Sinai Hospital

    New York, New York, 10029

    Recruiting

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • UPMC Presbyterian Hospital

    Pittsburgh, Pennsylvania, 15213

    Recruiting

  • UPMC Mercy Hospital

    Pittsburgh, Pennsylvania, 15243

    Recruiting

  • Medical City Plano

    Plano, Texas, 75075

    Recruiting

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

    Recruiting

  • University of Utah Healthcare

    Salt Lake City, Utah, 84132

    Recruiting

  • University of Texas Health Science Center

    San Antonio, Texas, 78229

    Recruiting

  • UCSD Medical Center - Hillcrest Hospital

    San Diego, California, 92103

    Recruiting

  • Harborview Medical Center

    Seattle, Washington, 98104

    Recruiting

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110

    Recruiting

  • Stanford University Medical Center

    Stanford, California, 94304

    Recruiting

  • Stony Brook University Hospital

    Stony Brook, New York, 11794

    Recruiting

  • Tampa General Hospital

    Tampa, Florida, 33606

    Recruiting

  • Montefiore Medical Center

    The Bronx, New York, 10467

    Recruiting

  • Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

    Recruiting

Other trials in United States

About this study

Official title: 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).

Read the 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.

Conditions
Ischemic Stroke
Being tested
Endovascular thrombectomy with any FDA-approved category POL or NRY device, Medical Management
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endovascular thrombectomy with any FDA-approved category POL or NRY deviceDevice

    Also called EVT, Endovascular Recanalization Therapy, Endovascular Therapy

    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)

  • Medical ManagementOther

    Medical Management (MM) may involve any combination of the following: intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol-lowering medications, and rehabilitative care.

Study groups in NCT06289985
Study groupRoleWhat they receive
Endovascular Therapy (EVT) Indication Expansion Domain: Low NIHSS StrataOtherAdult 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)
Receives: Device: Endovascular thrombectomy with any FDA-approved category POL or NRY device; Other: Medical Management
Endovascular Therapy (EVT) Indication Expansion Domain: Medium/Distal Occlusions StrataOtherAdult 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)
Receives: Device: Endovascular thrombectomy with any FDA-approved category POL or NRY device; Other: Medical Management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 90-day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2024
  2. Study start31 Jan 2025
  3. Primary completion31 Jan 2029 (estimated)
  4. Study completion31 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
Adaptive Bayesian Platform Trial evaluating multiple interventions in multiple domains.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06289985
Sponsor's protocol ID
STEP
Other IDs
1OT2NS129366-01
Acronym
STEP
Status last verified
Dec 2025
First submitted
13 Feb 2024
Last updated
4 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: 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.

Publications

  • Seners P, Cereda CW. Thrombectomy in Stroke With a Large Vessel Occlusion and Mild Symptoms: "Striving to Better, Oft We Mar What's Well?". Stroke. 2023 Sep;54(9):2276-2278. doi: 10.1161/STROKEAHA.123.044205. Epub 2023 Aug 1. No abstract available.

    PubMed 37526012

  • Feil K, Matusevicius M, Herzberg M, Tiedt S, Kupper C, Wischmann J, Schonecker S, Mengel A, Sartor-Pfeiffer J, Berger K, Dimitriadis K, Liebig T, Dieterich M, Mazya M, Ahmed N, Kellert L. Minor stroke in large vessel occlusion: A matched analysis of patients from the German Stroke Registry-Endovascular Treatment (GSR-ET) and patients from the Safe Implementation of Treatments in Stroke-International Stroke Thrombolysis Register (SITS-ISTR). Eur J Neurol. 2022 Jun;29(6):1619-1629. doi: 10.1111/ene.15272. Epub 2022 Feb 19.

    PubMed 35122371

Questions about this trial

What is this clinical trial studying?

A study testing Endovascular thrombectomy with any FDA-approved category POL or NRY device and Medical Management in people with Ischemic Stroke, run by Medical University of South Carolina at 41 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jordan Elm (843-876-1605, elmj@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global disability measured by Modified Rankin Score (time frame: 90-day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06289985, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.

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