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Идёт набор NCT05911568

Treatment With Endovascular Intervention for STroke Patients With Existing Disability

— Наблюдательное Stroke Stroke, Acute Stroke, Ischemic

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Endovascular Stroke Treatment, Medical Management.
Кому может быть актуально
Состояния в реестре: Stroke, Stroke, Acute, Stroke, Ischemic. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

  • Процедура 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
  • Другое 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.

Первичные конечные точки

  • modified Rankin Scale (mRS) [Срок оценки: 90 (±14) days after treatment initiation]
Вторичные конечные точки (4)
  • Disability-weighted (or utility-weighted) mRS [Срок оценки: 90 (±14) days after treatment initiation]
  • Return to the pre-stroke mRS level [Срок оценки: 90 (±14) days after treatment initiation]
  • EQ-5D-5L [Срок оценки: 90 (±14) days after treatment initiation]
  • Academic Medical Center - Linear Disability Scale (ALDS) [Срок оценки: 90 (±14) days after treatment initiation]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 25 центров
  • HonorHealth — Phoenix
  • Kaiser Permanente Los Angeles Medical Center — Los Angeles
  • University of California at Los Angeles — Los Angeles
  • Standford — Palo Alto
  • University of Cincinnati San Diego — San Diego
  • Swedish Medical Center — Englewood
  • Hartford Health Hospital — Hartford
  • Yale University — New Haven
  • … и ещё 17 центров

Идентификаторы

NCT: NCT05911568 · 2023-0299

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗