Treatment With Endovascular Intervention for STroke Patients With Existing Disability

Study Overview
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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.

Official Title
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Treatment With Endovascular Intervention for STroke Patients With Existing Disability

Conditions
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Stroke, Stroke, Acute, Stroke, Ischemic

Intervention / Treatment
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* Procedure: Endovascular Stroke Treatment
* Other: Medical Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stroke patients with moderate-to-severe pre-stroke disability<br>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<br>* 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<br>Other: Medical Management<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 90 (±14) days after treatment initiation | 
| Return to the pre-stroke mRS level | Returning to the pre-stroke mRS level post stroke | 90 (±14) days after treatment initiation | 
| EQ-5D-5L | Quality of life assessment scale with range: 0 (worst health) to 100 (best health) | 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. | 90 (±14) days after treatment initiation |