Меню
Набор по приглашению NCT06924996

Efficacy and Safety of Endovascular Thrombectomy in Acute Ischemic Stroke With Posterior Circulation Large Infarct

— Наблюдательное Acute Basilar Artery Occlusion Posterior Circulation Large Infarct

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 Thrombectomy (EVT).
Кому может быть актуально
Состояния в реестре: Acute Basilar Artery Occlusion, Posterior Circulation Large Infarct. Базовые параметры: 18 лет — 80 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Efficacy and Safety of Endovascular Thrombectomy in Acute Ischemic Stroke With Posterior Circulation Large Infarct: A Multicenter, Prospective, Cohort Study

Обзор

The purpose of this study is to evaluate whether endovascular thrombectomy (EVT) combined with best medical management (BMM) leads to better functional outcomes than BMM alone in patients with acute basilar artery occlusion with posterior circulation large infarct.

Подробное описание

This study is a multicenter, prospective, cohort study that prospectively enrolled consecutive patients with acute basilar artery occlusion and large core infarction in the posterior circulation, confirmed by imaging (CTA/MRA/DSA). Written informed consent was obtained from all participants or their legal representatives prior to enrollment. Patients were divided into the best medical management (BMM) group and the endovascular thrombectomy (EVT) group according to the treatment they received. This study adhered to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.

Вмешательства

  • Процедура Endovascular Thrombectomy (EVT)
    A maximum of six attempts to retrieve the thrombus in a single vessel can be made with any Solitaire AB/FR device or aspiration. In case an atherosclerotic lesion is found underlying the occlusive lesion, angioplasty and subsequent stenting through detachment of the Solitaire device will be allowed

Первичные конечные точки

  • Rate of modified Rankin scale 0-3 at 90 (±14) days after enrollment [Срок оценки: 90 (±14) days]
Вторичные конечные точки (3)
  • Ordinal Shift analysis of mRS score at 90 (±14) days after enrollment [Срок оценки: 90 (±14) days]
  • Rate of mRS 0-2 at 90 (±14) days after enrollment [Срок оценки: 90 (±14) days]
  • Rate of Functional health status and quality of life (EuroQol Five Dimensions) at 90 (±14) days after enrollment [Срок оценки: 90 (±14) days]

Критерии участия

Критерии включения

  • Age 18-80 years old;
  • Acute ischemic stroke in the posterior circulation, the onset of stroke (or last well known) to the enrollment time within 24 hours;
  • CTA/MRA/DSA confirmed acute basilar artery occlusion;
  • Posterior circulation large infarct: NCCT or DWI showed pc-ASPECTS ≤ 5 points, or pontine midbrain index (PMI) ≥ 3 points;
  • NIHSS score ≥10 points after the onset of the stroke and before enrollment;
  • Able to live independently before the onset of the disease (mRS score ≤2 points);
  • The subject or legal representative is able to sign the informed consent form.

Критерии исключения

  • Intracranial hemorrhage (except microhemorrhage) on CT/MRI ;
  • CT/MRI revealed large infarction in the cerebellar hemisphere, with significant mass effect causing compression of the fourth ventricle or brainstem;
  • CT or MRI showed bilateral complete thalamic infarction;
  • Occlusion of anterior and posterior circulation arteries confirmed by CTA/MRA/DSA;
  • The presence of intracranial tumors (except for small meningiomas and cerebral aneurysms with a diameter of <3mm);
  • Patients with known or highly suspected chronic basilar artery occlusion.;
  • Known severe allergy to contrast agents (except for mild rash);
  • Refractory hypertension (defined as systolic blood pressure > 185 mmHg or diastolic blood pressure >110 mmHg) that cannot be controlled by drug therapy;
  • Known pregnant or lactating females, or positive pregnancy test before enrollment;
  • Acute cerebral infarction within 48 hours after cardiovascular and cerebrovascular intervention or major surgery (patients more than 48 hours can be enrolled).

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 1 центр
  • Beijing Tiantan Hospital — Пекин

Идентификаторы

NCT: NCT06924996 · KY2023-106-02

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗