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Идёт набор NCT07356284

Emergent Large Vessel Occlusion Endovascular Rescue Therapy With Underlying Intracranial Stenosis

Фаза III С лечением Brain Stroke Stenting Treatment Acute 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: Mechanical Thrombectomy plus adjunct stenting, Mechanical Thrombectomy.
Кому может быть актуально
Состояния в реестре: Brain Stroke, Stenting Treatment, Acute Ischemic Stroke. 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
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

The study objective is to establish the safety and efficacy of endovascular adjunct stenting for patients undergoing mechanical thrombectomy (MT) that are found to have residual stenosis (70-99%) following attempted clot retrieval with either aspiration catheters or stent retrievers, per device instructions for use and device labeling.

Вмешательства

  • Процедура Mechanical Thrombectomy plus adjunct stenting
    Mechanical thrombectomy and adjunct stentiing
  • Устройство Mechanical Thrombectomy
    Mechanical thrombectomy only

Первичные конечные точки

  • Primary Efficacy Endpoint [Срок оценки: 90 (+/- 30) days post treatment]
  • Primary Safety Endpoint [Срок оценки: 90 (+/- 30 ) days post treatment]
Вторичные конечные точки (10)
  • Secondary Safety Endpoint [Срок оценки: 8 (+/- 3) days or Discharge post treatment]
  • Secondary Safety Endpoint [Срок оценки: Immediate post treatment]
  • Secondary Safety Endpoint [Срок оценки: Immediate post treatment]
  • Secondary Safety Endpoint [Срок оценки: Immediate post treatment]
  • Secondary Safety Endpoint [Срок оценки: 1 year (+/- 60) days post treatment]
  • Secondary Safety Endpoint [Срок оценки: Immediate post treatment]
  • Secondary Safety Endpoint [Срок оценки: 1 year (+/- 60) days post treatment]
  • Secondary Safety Endpoint [Срок оценки: 1 year (+/- 60) days post treatment]
  • Secondary Safety Endpoints [Срок оценки: 1 year (+/- 60) days post treatment]
  • Secondary Safety Endpoint [Срок оценки: 1 year (+/- 60) days post treatment]

Критерии участия

Критерии включения

  • 18 to 80 years of age
  • Presenting with symptoms consistent with AIS
  • Imaging evidence of an anterior occlusion of the Internal Carotid Artery (ICA) or Middle Cerebral Artery Main Stem (MCA M1), or proximal M2 segment AND residual 70-99% stenosis of the index artery following attempted clot retrieval with either aspiration catheters or stent retrievers, per device instructions for use and device labeling
  • NIHSS ≥ 6
  • Ability to randomize within 24 hours of stroke onset.
  • Pre-stroke mRS score 0-2
  • Ability to obtain signed informed consent.
  • ASPECTS Score ≥ 6 by non-contrast CT scan
  • Score-ICAD score of ≥11 points at screening and/or persistent stenotic occlusion of ≥70% after MT
  • If indicated, thrombolytic therapy shall be initiated per the institution's usual care and the most recent version of the AHA/ASA Guidelines. Subjects eligible for IV thrombolysis should receive it without delay.
  • For subjects presenting >6 hours from stroke onset, infarct core volume <50 cc quantified by CTP

Критерии исключения

  • Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test
  • Known severe allergy (more than a rash) to contrast media uncontrolled by medications.
  • CT evidence of the following conditions:
  • Midline shift or herniation
  • Evidence of intracranial hemorrhage
  • Mass effect with effacement of the ventricles
  • Acute bilateral strokes
  • Contraindication to antiplatelet (aspirin, clopidogrel, ticagrelor, cangrelor) or contrast agents
  • Intracranial tumors other than small meningioma, that do not require surgery for at least one year post randomization. Small meningioma is defined as a lesion measuring ≤20mm in maximum diameter or ≤4cm3 in volume, with no associated mass effect, peritumoral edema, or progressive neurological symptoms
  • Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of >3.0 or Partial Thromboplastin Time (PTT) >3 times of normal
  • Baseline platelet count <80,000 per microliter (µl)
  • Life expectancy less than one year prior to stroke onset
  • Participation in another randomized clinical trial that could confound the evaluation of the study outcomes.
  • Any other condition (in the opinion of the site investigator) that precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was performed
  • New diagnosis of atrial fibrillation or a history of atrial fibrillation
  • Suspected device-induced vasospasm defined as smooth transient narrowing of the target vessel
  • Vessel dissection including any of the following: presence of dissection flap, false lumen, contrast stagnation in the vessel wall, and/or improving stenosis

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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

США · 1 центр
  • ProMedica Toledo Hospital — Toledo

Идентификаторы

NCT: NCT07356284 · EVEREST

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗