Recruiting

Endovascular InterventionTreatment With Endovascular Intervention for STroke Patients With Existing Disability

Sponsor:

University of Cincinnati

Code:

NCT05911568

Conditions

Stroke

Stroke, Acute

Stroke, Ischemic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Endovascular Stroke Treatment

Medical Management

Study Details

Brief summary:

TESTED will compare the risks and benefits of endovascular thrombectomy (EVT) to medical management (no EVT) in ischemic stroke patients who have a blockage in one of the large blood vessels in the brain and have a moderate-to-severe disability prior to their stroke.

Conditions

Stroke

Stroke, Acute

Stroke, Ischemic

Study ID

NCT05911568

Start date

Nov 16, 2023

Status verified date

Aug, 2026

Completion date

Apr 15, 2028

Anticipated

Primary completion date

Jan 15, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adult patients (≥18 years)
2. Moderate-to-severe pre-stroke functional disability, defined as mRS 3-4, for at least 3 months prior to stroke onset
3. Presenting to study hospital within 24 hours of last known well time
4. Diagnosis of acute ischemic stroke
5. Intracranial causative occlusion of the internal carotid artery or the M1 or dominant M2 segments of the middle cerebral artery visualized on the baseline CT(or MR) angiogram
6. Presenting CT Alberta Stroke Program Early CT (ASPECT) score ≥3 or MRI ASPECT score ≥4
7. Presenting NIH Stroke Scale score ≥6
8. Informed consent from patient if competent or from legally authorized representative

Exclusion Criteria:

1. Known diagnosis of a terminal cancer or terminal illness at the time of stroke
2. Assessment of pre-stroke functional status cannot be performed during the hospital stay
3. Pre-stroke disability deemed temporary in the investigator's opinion (for example, recovering from a general medical illness or traumatic bodily injury)

Study Design

Enrollment

1060 participants

Anticipated

Interventions and Outcome Measures

Arms

Stroke patients with moderate-to-severe pre-stroke disability

Patients with pre-stroke modified Rankin scale score 3 or 4, presenting with a anterior circulation large vessel occlusion stroke within 24 hours of last known well

Interventions

Endovascular Stroke Treatment

Patients who receive endovascular stroke treatment when they are admitted into the hospital, as determined by their clinical care team. Endovascular stroke treatment consist of catheter-based treatment for the blood clot causing the acute ischemic stroke

Medical Management

Patients who receive MMM when they are admitted into the hospital, as determined by their clinical care team. MMM may involve any combination of the following: intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol-lowering medications, and rehabilitative care. Specifically, this treatment does not involve endovascular stroke treatment.

Primary outcome measure

modified Rankin Scale (mRS) [ Time Frame: 90 (±14) days after treatment initiation ]

Central Contacts and Locations

Central contacts

Eva Mistry, MD

513-558-1291 mistryea@ucmail.uc.edu

Naima Griffin

513-558-0125 griffna@ucmail.uc.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Principal Investigator:

Toby Gropen, MD

HonorHealth

Recruiting

Phoenix, Arizona, United States, 85013

Principal Investigator:

Ashu Jadhav, MD

Kaiser Permanente Los Angeles Medical Center

Recruiting

Los Angeles, California, United States, 90027

Principal Investigator:

Shayandokht Taleb, MD

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Principal Investigator:

Benedict Pereira, MD

University of California at Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Principal Investigator:

Jeffrey Saver, MD

Stanford University

Recruiting

Palo Alto, California, United States, 94305

University of California San Diego

Recruiting

San Diego, California, United States, 92121

Hartford Health Hospital

Recruiting

Hartford, Connecticut, United States, 06106

Principal Investigator:

Tapan Mehta, MD

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

Principal Investigator:

Adam DeHavenon, MD

University of Miami

Recruiting

Miami, Florida, United States, 33125

Principal Investigator:

Robert Starke, MD

Baptist Hospital of Miami

Recruiting

Miami, Florida, United States, 33176

Principal Investigator:

Felipe De Los Rios La Rosa, MD

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Principal Investigator:

Brian Howard, MD

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Principal Investigator:

Mohamad AbdalKader

Barnes Jewish Hospital

Recruiting

Saint Loius, Missouri, United States, 63110

New York University

Recruiting

Brooklyn, New York, United States, 11220

Principal Investigator:

Aaron Lord

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Principal Investigator:

Shahram Majidi, MD

Columbia University

Recruiting

New York, New York, United States, 10032

Principal Investigator:

Joshua Wiley, MD

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Principal Investigator:

Stacie Demel, DO, PhD

TriHealth Good Samaritan Hospital

Recruiting

Cincinnati, Ohio, United States, 45220

Principal Investigator:

Faraze Niazi, MD

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Principal Investigator:

Jenny Tsai, MD

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Principal Investigator:

Vivien Lee, MD

Ascension St. John

Recruiting

Tulsa, Oklahoma, United States, 74104

Principal Investigator:

Rahul Rahangdale, MD

Providence St. Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Principal Investigator:

Amit Kansara, MD

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Principal Investigator:

Raul Nogueira, MD

Baptist Memorial Hospital

Recruiting

Memphis, Tennessee, United States, 38120

Principal Investigator:

Violiza Inoa, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Principal Investigator:

Deborah Kerrigan, MD

University of Texas at Austin

Recruiting

Austin, Texas, United States, 78712

Principal Investigator:

Hamidreza Saber, MD

Houston Methodist Neurological Institute

Recruiting

Houston, Texas, United States, 77030

Principal Investigator:

Tanu Garg, MD

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Principal Investigator:

Jennifer Majersik, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22904

Principal Investigator:

Cesarina Thohan, MD

University of Washington

Recruiting

Seattle, Washington, United States, 98104

Principal Investigator:

David Tirschwell, MD

More Information

Sponsor

University of Cincinnati

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2026-09-02.