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Massive stroke trial aims to Fine-Tune clot removal for better recovery

NCT ID NCT06289985

Disease control Sponsor: Medical University of South Carolina Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is for people having a stroke caused by a blocked artery in the brain. It compares different methods of removing the clot (thrombectomy) to find which works best. About 1600 adults will take part, and the goal is to reduce long-term disability.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

ischemic stroke large artery stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ischemic stroke

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    41 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Barnes Jewish Hospital

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Buffalo General Medical Center

    RECRUITING

    Buffalo, New York, 14203, United States

  • Carolinas Medical Center

    RECRUITING

    Charlotte, North Carolina, 28207, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Cooper University Hospital

    RECRUITING

    Camden, New Jersey, 08103, United States

  • Grady Memorial Hospital

    RECRUITING

    Atlanta, Georgia, 30303, United States

  • Harborview Medical Center

    RECRUITING

    Seattle, Washington, 98104, United States

  • Hartford Hospital

    RECRUITING

    Hartford, Connecticut, 06106, United States

  • Hospital of the University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Jackson Memorial Hospital

    RECRUITING

    Miami, Florida, 33136, United States

  • Kaiser Permanente Los Angeles Medical Center

    RECRUITING

    Los Angeles, California, 90027, United States

  • M Health Fairview Southdale Hospital

    RECRUITING

    Edina, Minnesota, 55435, United States

  • M Health Fairview University of Minnesota Medical Center

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • Medical City Plano

    RECRUITING

    Plano, Texas, 75075, United States

  • Medical University of South Carolina University Hospital

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Memorial Hermann Texas Medical Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10467, United States

  • NYU Langone Hospital

    RECRUITING

    Brooklyn, New York, 11220, United States

  • OSU Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Rhode Island Hospital

    RECRUITING

    Providence, Rhode Island, 02903, United States

  • Ronald Reagan UCLA Medical Center

    RECRUITING

    Los Angeles, California, 90095, United States

  • Stanford University Medical Center

    RECRUITING

    Stanford, California, 94304, United States

  • Stony Brook University Hospital

    RECRUITING

    Stony Brook, New York, 11794, United States

  • Tampa General Hospital

    RECRUITING

    Tampa, Florida, 33606, United States

  • The Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

  • UCSD Health La Jolla

    RECRUITING

    La Jolla, California, 92093, United States

  • UCSD Medical Center - Hillcrest Hospital

    RECRUITING

    San Diego, California, 92103, United States

  • UH Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • UPMC Mercy Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15243, United States

  • UPMC Presbyterian Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • UVA Medical Center

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • University of Alabama Hospital

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Cincinnati Medical Center

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of Iowa Hospitals & Clinics

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Texas Health Science Center

    RECRUITING

    San Antonio, Texas, 78229, United States

  • University of Utah Healthcare

    RECRUITING

    Salt Lake City, Utah, 84132, United States

  • Wake Forest Baptist Medical Center

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Yale New Haven Hospital

    RECRUITING

    New Haven, Connecticut, 06511, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.