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Treatment With Endovascular Intervention for STroke Patients With Existing Disability

Sponsored by University of Cincinnati

About this study

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 pat…

Where this study is enrolling (4)

Who can participate

Inclusion criteria

  • ✓1. Adult patients (≥18 years)
  • ✓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

  • ✕1. Known diagnosis of a terminal cancer or terminal illness at the time of stroke
  • ✕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)

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Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.