An observational study in Stroke, Stroke, Acute and Stroke, Ischemic, sponsored by University of Cincinnati. Recruiting at 35 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by University of Cincinnati · Observational
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.
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.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 1,060 is above the median of 300 across 771 observational studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →University of Cincinnati is the lead sponsor of 324 studies on the registry; 42 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 15 (63%) have results posted.
Compared within Ischemic Stroke, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Stroke. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Procedure: Endovascular Stroke Treatment · Other: Medical Management
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.
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)
Time frame: 90 (±14) days after treatment initiation
Disability-weighted (or utility-weighted) mRS
Standard utility weights applied to the mRS categories as follows: 1.0 for mRS level 0; 0.91 for mRS level 1; 0.76 for mRS level 2; 0.65 for mRS level 3; 0.33 for mRS level 4; 0 for mRS level 5; and 0 for mRS level 6
Time frame: 90 (±14) days after treatment initiation
Return to the pre-stroke mRS level
Returning to the pre-stroke mRS level post stroke
Time frame: 90 (±14) days after treatment initiation
EQ-5D-5L
Quality of life assessment scale with range: 0 (worst health) to 100 (best health)
Time frame: 90 (±14) days after treatment initiation
Academic Medical Center - Linear Disability Scale (ALDS)
Generic item bank that measures the disability status of patients with a broad range of diseases, as expressed by the ability to perform activities in daily living.
Time frame: 90 (±14) days after treatment initiation
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)
Time frame: At hospital discharge
Montreal Cognitive Assessment (MoCA)
Montreal Cognitive Assessment (MoCA) (Note: MoCA range: 0-30, higher scores mean better outcome)
Time frame: 90 (±14) days after treatment initiation
Barthel Index Scale
Barthel Index range: 0-100, higher scores mean participant is independent
Time frame: 90 (±14) days after treatment initiation
Initial residence level or better time during first 90 days post-stroke
Number of days spend at the initial residence level or better during the first 90 days post-stroke
Time frame: 90 days after treatment initiation
Zarit's Burden Interview (ZBI)
ZBI is a measure of caregiving burden that includes a 22 item interview. Each item on the interview is a statement which the caregiver is asked to endorse using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). We will use the 4 item version of the ZBI which has good correlation with the full version.
Time frame: 90 (±14) days after treatment initiation
Extended Thrombolysis in Cerebral Ischemia scale
The 7-point scale of eTICI is as follows: eTICI0 = 0% reperfusion; eTICI 1 = minimal flow past the occlusion but no perfusion ; eTICI2a = 1-49% reperfusion; eTICI2b50 = 50-66% reperfusion; eTICI2b67 = 67-89% reperfusion; eTICI2c = 90-99% reperfusion; eTICI3 = complete reperfusion
Time frame: At the end of EVT procedure
Death
Time frame: 90 (±14) after treatment initiation
Symptomatic intracranial hemorrhage
Evaluate modified Heidelberg definition
Time frame: 24 (±6) hours
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Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: One year after completing of the final analysis
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