RecruitingNCT05911568

Treatment With Endovascular Intervention for STroke Patients With Existing Disability


Sponsor

University of Cincinnati

Enrollment

1,060 participants

Start Date

Nov 16, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • Adult patients (≥18 years)
  • Moderate-to-severe pre-stroke functional disability, defined as mRS 3-4, for at least 3 months prior to stroke onset
  • Presenting to study hospital within 24 hours of last known well time
  • Diagnosis of acute ischemic stroke
  • 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
  • Presenting CT Alberta Stroke Program Early CT (ASPECT) score ≥3 or MRI ASPECT score ≥4
  • Presenting NIH Stroke Scale score ≥6
  • Informed consent from patient if competent or from legally authorized representative

Exclusion Criteria3

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

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Interventions

PROCEDUREEndovascular 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

OTHERMedical 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.


Locations(19)

HonorHealth

Phoenix, Arizona, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

University of California at Los Angeles

Los Angeles, California, United States

Swedish Medical Center

Englewood, Colorado, United States

Hartford Health Hospital

Hartford, Connecticut, United States

Yale University

New Haven, Connecticut, United States

University of Miami

Miami, Florida, United States

Emory University

Atlanta, Georgia, United States

Boston Medical Center

Boston, Massachusetts, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Columbia University

New York, New York, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Providence St. Vincent Medical Center

Portland, Oregon, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Baptist Memorial Hospital

Memphis, Tennessee, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

University of Texas at Austin

Austin, Texas, United States

University of Washington

Seattle, Washington, United States

West Virginia University

Morgantown, West Virginia, United States

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NCT05911568


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