Treatment With Endovascular Intervention for STroke Patients With Existing Disability

NCT ID: NCT05911568

Last Updated: 2026-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1060 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-16

Study Completion Date

2028-04-15

Brief Summary

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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.

Detailed Description

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People with disabilities can suffer acute ischemic stroke (AIS). Endovascular clot removal is a breakthrough therapy for large vessel occlusion (LVO) AIS. Pre-stroke disabled patients were excluded from pivotal EVT stroke trials, so whether EVT is effective for those with pre-stroke disability is not known. As a result, two competing, widely-practiced, treatment paradigms have emerged based on individual practitioners' extrapolation of EVT benefits and safety from patients without a pre-stroke disability to those with disability: 1) Multimodal Medical Management (MMM; using intravenous thrombolysis, antiplatelets, anti-hypertensives, cholesterol lowering medications, and other rehabilitative measures, as indicated) without EVT, and 2) EVT with the background of MMM.

TESTED will enroll patients with LVO-AIS who have a pre-existing disability, defined as pre-stroke modified Rankin score (mRS) 3 and 4, at 12 geographically distinct comprehensive stroke centers serving diverse race-ethnic and socioeconomic populations. The central objective of TESTED is to determine the comparative effectiveness and safety of these two different practice paradigms.

Conditions

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Stroke Stroke, Acute Stroke, Ischemic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Endovascular Stroke Treatment

Intervention Type PROCEDURE

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

Intervention Type OTHER

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.

Interventions

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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

Intervention Type PROCEDURE

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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Eva A. Mistry

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva Mistry, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Jeffrey Saver, MD

Role: PRINCIPAL_INVESTIGATOR

Ronald Reagan UCLA Medical Center

J Mocco, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Heidi Sucharew, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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HonorHealth

Phoenix, Arizona, United States

Site Status RECRUITING

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Site Status RECRUITING

University of California at Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Swedish Medical Center

Englewood, Colorado, United States

Site Status RECRUITING

Hartford Health Hospital

Hartford, Connecticut, United States

Site Status RECRUITING

Yale University

New Haven, Connecticut, United States

Site Status RECRUITING

University of Miami

Miami, Florida, United States

Site Status RECRUITING

Emory University

Atlanta, Georgia, United States

Site Status RECRUITING

Boston Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status RECRUITING

Columbia University

New York, New York, United States

Site Status RECRUITING

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Providence St. Vincent Medical Center

Portland, Oregon, United States

Site Status RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Baptist Memorial Hospital

Memphis, Tennessee, United States

Site Status RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status RECRUITING

University of Texas at Austin

Austin, Texas, United States

Site Status RECRUITING

University of Washington

Seattle, Washington, United States

Site Status RECRUITING

West Virginia University

Morgantown, West Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Eva Mistry, MD

Role: CONTACT

513-558-1291

Naima Griffin

Role: CONTACT

513-558-0125

Facility Contacts

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Ashu Jadhav, MD

Role: primary

Shayandokht Taleb, MD

Role: primary

Jeffrey Saver, MD

Role: primary

Donald Frei, MD

Role: primary

Tapan Mehta, MD

Role: primary

Adam DeHavenon, MD

Role: primary

Robert Starke, MD

Role: primary

Brian Howard, MD

Role: primary

Mohamad AbdalKader, MD

Role: primary

Shahram Majidi, MD

Role: primary

Joshua Wiley, MD

Role: primary

Stacie Demel, DO, PhD

Role: primary

Amit Kansara, MD

Role: primary

Raul Nogueira, MD

Role: primary

Violiza Inoa, MD

Role: primary

Michael Froehler, MD

Role: primary

Hamidreza Saber, MD

Role: primary

David Tirschwell, MD

Role: primary

Ansaar Rai, MD

Role: primary

Other Identifiers

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2023-0299

Identifier Type: -

Identifier Source: org_study_id

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