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New stroke trial combines clot removal with stenting to save brain function

NCT ID NCT05611242

Disease control Sponsor: Mercy Health Ohio 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This Phase 3 trial tests whether adding carotid artery stenting to standard mechanical clot removal improves recovery in people with acute ischemic stroke caused by a blockage in the internal carotid artery. About 404 participants aged 18-79 will be randomly assigned to receive either clot removal plus stenting or clot removal alone. The main goal is to see if the combined procedure leads to less disability 90 days after the stroke.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Mechanical thrombectomy and carotid stenting with antiplatelet therapy
What this could lead to
If successful, this could establish a new standard procedure for treating certain types of severe stroke, potentially reducing long-term disability.
What could go wrong
This is a Phase 3 trial, but adding stenting carries risks like bleeding or vessel damage. The benefit over standard clot removal alone is not yet proven.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 404 people

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

Started

May 2024

Expected to finish

May 2027

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 to 79 years

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.

Inclusion Criteria: 1. 18 to 79 years of age (before the 80th birthday) 2. Presenting with symptoms consistent with AIS 3. Imaging evidence of an anterior circulation occlusion of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1), or proximal M2 segment AND extra-cranial proximal carotid occlusion / severe stenosis related to atherosclerosis requiring treatment on non-invasive imaging ≥70% 4. NIHSS ≥ 4 5. Ability to randomize and start endovascular therapy within 16 hours of stroke onset 6. Pre-stroke mRS score 0-2 7. Ability to obtain signed informed consent 8. ASPECTS Score ≥7 via non-contrast CT or MRI (DWI) for subjects ≤6 hours from stroke onset OR ASPECTS Score ≥7 + infarct core volume \<50 cc quantified by CTP (rCBF\<30%) OR \<25 cc quantified by MRI-DWI (AxBxC/2) for subjects with endovascular therapy starting between \>6h to 16 hours from stroke onset, given the need for antiplatelet therapy. 9. Acute Neurological Deficit with Imaging evidence of Tandem Lesion: Extracranial carotid occlusion (70% to 100% Using NACET criteria) With or without intracranial vascular occlusion 10. Must be ineligible for IV t-PA therapy or have failed IV t-PA therapy Exclusion Criteria: 1. Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test 2. Known severe allergy (more than a rash) to contrast media uncontrolled by medications 3. Refractory hypertension (defined as persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg) despite medication 4. CT evidence of the following conditions: * Midline shift or herniation * Evidence of intracranial hemorrhage * Mass effect with effacement of the ventricles 5. Acute bilateral strokes 6. Contraindication to antiplatelet (Aspirin, Plavix, Ticagrelor, Cangrelor), or thrombolytic therapy, or contrast agents. 7. Intracranial tumors other than small meningioma that does not require surgery for one year post randomization 8. Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of \>1.7 or Partial Thromboplastin Time (PTT) \> 3 times of normal 9. Baseline platelet count \<100,000 per microliter (μl) 10. Life expectancy less than one year prior to stroke onset 11. Participation in another randomized clinical trial that could confound the evaluation of the study outcomes 12. Any other condition (in the opinion of the site investigator) that precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was performed 13. Proximal carotid stenosis secondary to dissection or vasculitis (.e.g. Takayasu's Arteritis)

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Conditions

The condition(s) this trial relates to.

ischemic stroke stroke disorder

As listed by the trial registrant

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

Acute 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

    51 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

  • Albany Medical College

    RECRUITING

    Albany, New York, 12208, United States

  • Allegheny Health Network Research Institute

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Ascension/Alexian Brothers Health System

    RECRUITING

    Chicago, Illinois, 60606, United States

  • Baptist Health Research Institute

    RECRUITING

    Jacksonville, Florida, 32207, United States

  • Baptist Healthcare Systems, Inc

    RECRUITING

    Lexington, Kentucky, 40299, United States

  • Boca Raton - Baptist Health

    RECRUITING

    Boca Raton, Florida, 33486, United States

  • Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • Bronson Methodist Hospital/Western Michigan University Homer Stryker M.D. School of Medicine

    RECRUITING

    Kalamazoo, Michigan, 49007, United States

  • California Pacific Medical Center/Mils Peninsula Medical Center

    RECRUITING

    San Francisco, California, 94107, United States

  • DHR Health Institute for Research and Development

    NOT_YET_RECRUITING

    Edinburg, Texas, 78539, United States

  • Delray Medical Center

    RECRUITING

    Delray Beach, Florida, 33484, United States

  • Glendale Adventist Medical Center

    RECRUITING

    Glendale, California, 91206, United States

  • HCA Houston Kingwood

    RECRUITING

    Houston, Texas, 77004, United States

  • Indiana University Health Methodist Hospital

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • JFK University Medical Center

    RECRUITING

    Edison, New Jersey, 08837, United States

  • Louisiana State University Health Sciences Center at Shreveport

    RECRUITING

    Shreveport, Louisiana, 71103, United States

  • McLaren Flint

    RECRUITING

    Flint, Michigan, 48532, United States

  • McLaren Macomb

    RECRUITING

    Mount Clemens, Michigan, 48043, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Mercy Health St. Vincent Medical Center

    RECRUITING

    Toledo, Ohio, 43608, United States

  • Michigan State University

    RECRUITING

    Lansing, Michigan, 48912, United States

  • Mobile Infirmary Medical Center

    RECRUITING

    Mobile, Alabama, 36607, United States

  • Mount Sinai Hospital

    RECRUITING

    New York, New York, 10029, United States

  • Munster Community Hospital

    RECRUITING

    Munster, Indiana, 46321, United States

  • Northwell Health- South Shore University Hospital

    RECRUITING

    Bay Shore, New York, 11706, United States

  • Northwestern Medicine Central DuPage Hospital

    RECRUITING

    Winfield, Illinois, 60190, United States

  • Ochsner Medical Center

    RECRUITING

    New Orleans, Louisiana, 70121, United States

  • OhioHealth Research Institute

    RECRUITING

    Columbus, Ohio, 43214, United States

  • Orlando Health, Inc.

    RECRUITING

    Orlando, Florida, 32806, United States

  • Piedmont Healthcare

    RECRUITING

    Atlanta, Georgia, 30309, United States

  • Pomona Valley

    RECRUITING

    Pomona, California, 91767, United States

  • Rutgers, The State University

    RECRUITING

    Piscataway, New Jersey, 08854, United States

  • SSM Health DePaul Hospital

    RECRUITING

    St Louis, Missouri, 63044, United States

  • Semmes-Murphey Foundation

    RECRUITING

    Memphis, Tennessee, 38120, United States

  • St. Mary's Medical Center

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • Sutter Institute for Medical Research

    NOT_YET_RECRUITING

    Sacramento, California, 95816, United States

  • University of California, Irvine

    RECRUITING

    Irvine, California, 92697, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Florida Health Jacksonville

    RECRUITING

    Jacksonville, Florida, 32209, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Massachusetts

    RECRUITING

    Worcester, Massachusetts, 01655, United States

  • University of Miami School of Medicine

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Oklahoma Health Sciences Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • University of South Florida

    RECRUITING

    Tampa, Florida, 33606, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • University of Washington

    NOT_YET_RECRUITING

    Seattle, Washington, 98195, United States

  • Valley Medical Center

    RECRUITING

    Renton, Washington, 98055, United States

  • Wake Forest University Health Sciences

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • WellSpan Health

    RECRUITING

    York, Pennsylvania, 17403, United States

  • WellStar Health System, Inc

    RECRUITING

    Marietta, Georgia, 30062, United States

  • West Virginia Univeristy

    RECRUITING

    Morgantown, West Virginia, 26506, United States

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