Treatment With Endovascular Intervention for STroke Patients With Existing Disability
NCT ID: NCT05911568
Last Updated: 2026-01-27
Study Results
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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RECRUITING
1060 participants
OBSERVATIONAL
2023-11-16
2028-04-15
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
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
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.
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
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.
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of California, Los Angeles
OTHER
Icahn School of Medicine at Mount Sinai
OTHER
University of Cincinnati
OTHER
Responsible Party
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Eva A. Mistry
Assistant Professor
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
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
Countries
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Central Contacts
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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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