Treatment With Endovascular Intervention for STroke Patients With Existing Disability
TESTED
1 other identifier
observational
1,060
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2023
Longer than P75 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 9, 2023
CompletedFirst Posted
Study publicly available on registry
June 22, 2023
CompletedStudy Start
First participant enrolled
November 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 15, 2028
April 15, 2026
April 1, 2026
4.2 years
June 9, 2023
April 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
modified Rankin Scale (mRS)
Score of 0-3, 4, 5 or 6 on the modified Rankin Scale (mRS) (Note: mRS range: 0 (no residual symptoms) to 6 (death)
90 (±14) days after treatment initiation
Secondary Outcomes (4)
Disability-weighted (or utility-weighted) mRS
90 (±14) days after treatment initiation
Return to the pre-stroke mRS level
90 (±14) days after treatment initiation
EQ-5D-5L
90 (±14) days after treatment initiation
Academic Medical Center - Linear Disability Scale (ALDS)
90 (±14) days after treatment initiation
Other Outcomes (8)
modified Rankin Scale (mRS)
At hospital discharge
Montreal Cognitive Assessment (MoCA)
90 (±14) days after treatment initiation
Barthel Index Scale
90 (±14) days after treatment initiation
- +5 more other outcomes
Study Arms (1)
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
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
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
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. They will be consented up to 72 hours after stroke onset in the acute hospitalization setting.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Cincinnatilead
- University of California, Los Angelescollaborator
- Icahn School of Medicine at Mount Sinaicollaborator
- Patient-Centered Outcomes Research Institutecollaborator
Study Sites (25)
HonorHealth
Phoenix, Arizona, 85013, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
University of California at Los Angeles
Los Angeles, California, 90095, United States
Standford
Palo Alto, California, 94305, United States
University of Cincinnati San Diego
San Diego, California, 92121, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
Hartford Health Hospital
Hartford, Connecticut, 06106, United States
Yale University
New Haven, Connecticut, 06510, United States
University of Miami
Miami, Florida, 33125, United States
Emory University
Atlanta, Georgia, 30322, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Barnes Jewish Hospital
Saint Loius, Missouri, 63110, United States
New York University
Brooklyn, New York, 11220, United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Columbia University
New York, New York, 10032, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
Providence St. Vincent Medical Center
Portland, Oregon, 97225, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Baptist Memorial Hospital
Memphis, Tennessee, 38120, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
University of Texas at Austin
Austin, Texas, 78712, United States
University of Washington
Seattle, Washington, 98104, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eva Mistry, MD
University of Cincinnati
- PRINCIPAL INVESTIGATOR
Jeffrey Saver, MD
Ronald Reagan UCLA Medical Center
- PRINCIPAL INVESTIGATOR
J Mocco, MD
Icahn School of Medicine at Mount Sinai
- PRINCIPAL INVESTIGATOR
Heidi Sucharew, PhD
University of Cincinnati
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 9, 2023
First Posted
June 22, 2023
Study Start
November 16, 2023
Primary Completion (Estimated)
January 15, 2028
Study Completion (Estimated)
April 15, 2028
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- One year after completing of the final analysis