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Идёт набор NCT06763458

Balloon Angioplasty for Minor Unstable Stroke With IntraCranial Atherosclerosis Stenosis (BAMUS-ICAS)

Без фазы С лечением Ischemic Stroke

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: Submaximal balloon angioplasty.
Кому может быть актуально
Состояния в реестре: Ischemic Stroke. 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
Китай
Следующий шаг
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Официальное название

Balloon Angioplasty for Minor Unstable Stroke With IntraCranial Atherosclerosis Stenosis (BAMUS-ICAS): a Prospective, Randomized, Multi-center Study

Обзор

Intracranial atherosclerotic stenosis (ICAS) is a common cause of stroke, especially in East and South Asia, and is significantly associated with stroke recurrence and early neurological deterioration (END) despite aggressive medical management. Minor stroke (National Institutes of Health Stroke, NIHSS score ≤ 5) patients with ICAS often has higher risk of END. The early realization of blood flow patency is closely related to the improvement of patient outcomes. Submaximal balloon angioplasty (SBA) as a safer and simpler intervention which can improve cerebral blood flow. Thus, SBA may be an effective strategy for preventing END in acute ischemic stroke patients with ICAS.

Вмешательства

  • Процедура Submaximal balloon angioplasty
    The goal of submaximal balloon angioplasty is to use the balloon to improve the stenosis of the criminal artery by more than 20%.

Первичные конечные точки

  • Proportion of early neurological deterioration (NIHSS score increase of 4 points or more) [Срок оценки: at 24±8 hours]
Вторичные конечные точки (12)
  • The decrease of NIHSS score [Срок оценки: at 24±8 hours]
  • The decrease of NIHSS score [Срок оценки: at 10±2 days]
  • Proportion of early neurological improvement (NIHSS score decline of 4 points or 0) [Срок оценки: at 24±8 hours]
  • Proportion of patients with modified Rankin Score 0 to 1 [Срок оценки: at 90±7 days]
  • Proportion of patients with modified Rankin Score 0 to 2 [Срок оценки: at 90±7 days]
  • Distribution of patients with modified Rankin Score [Срок оценки: at 90±7 days]
  • the occurence of stroke or other cardiovascular events [Срок оценки: at 90±7 days]
  • ischemic stroke in the culprit artery territory [Срок оценки: at 90±7 days]
  • Incidence of symptomatic intracranial hemorrhage (ECASS-III criteria) [Срок оценки: at 24±8 hours]
  • Proportion of occurrence of cerebral parenchymal hemorrhage types (PH1) and (PH2) [Срок оценки: at 24±8 hours]
  • Proportion of serious adverse events [Срок оценки: at 24±8 hours]
  • Proportion of all-cause deaths [Срок оценки: at 10±2 days]

Критерии участия

Критерии включения

  • Over 18 years of age;
  • Minor ischemic stroke within 1 week of onset (NIHSS≤5);
  • Have received the best drug treatment (dual antibody, anti-plate combined with anticoagulation), but symptoms still have measurable fluctuations or progression (NIHSS increased by at least 1 point);
  • Symptoms fluctuate to the time of receiving balloon dilation within 24 hours;
  • The etiology was considered to be severe stenosis of the responsible vessels due to intracranial arteriosclerosis (70-99% stenosis), or perforator artery disease with severe stenosis of the carrier artery (confirmed by MRA, CTA or DSA);
  • Patients with first onset or past onset without sequelae such as limb paralysis should not affect the score of this NIHSS, and mRS Score of patients with past onset should be less than 2 points;
  • Patients or family members sign informed consent.

Критерии исключения

  • Patients who have developed large intracranial vessel occlusion;
  • Intracranial hemorrhagic diseases in the past 3 months: cerebral hemorrhage, subarachnoid hemorrhage, etc.;
  • Non-atherosclerotic disease-related stenosis: arterial dissection, moya-moya disease, arterioinflammatory disease, etc.
  • Clotting disorders or systemic bleeding tendency or platelets less than 100,000;
  • Complicated with serious infection or liver, kidney and other serious diseases;
  • Patients with severe inability to control hypertension (systolic blood pressure >200mmHg or diastolic blood pressure >110mmHg);
  • Women who are pregnant, have a pregnancy plan or are breastfeeding;
  • Complicated with other serious diseases, life expectancy < 6 months; Other conditions deemed inappropriate for participation in this study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • General Hospital of Northern Theater Command — Шэньян

Идентификаторы

NCT: NCT06763458 · Y(2024)262

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗