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Идёт набор NCT07749170

FORWARD: Functional Outcomes in Real-World Treatment And Revascularization of Non-dominant and Distal M2 Occlusions

— Наблюдательное Acute Ischemic Stroke Acute Ischemic Stroke (AIS) Related to a Distal Occlusion

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, Medical Management.
Кому может быть актуально
Состояния в реестре: Acute Ischemic Stroke, Acute Ischemic Stroke (AIS) Related to a Distal Occlusion. 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

The objective of this study is to collect safety and effectiveness data on the Penumbra System reperfusion catheters in participants with isolated primary non-dominant and distal M2 occlusions who undergo endovascular mechanical thrombectomy (EVT). Additionally, this study aims to observe characteristics and outcomes of participants treated with medical management (MM) alone and those who receive EVT + MM per current medical practice.

Подробное описание

FORWARD is a prospective, multicenter, observational study that will be conducted internationally.

Participants who satisfy all inclusion criteria and none of the exclusion criteria will be eligible for enrollment. They will receive treatment according to the physicians' clinical judgement per standard of care at their institution.

Вмешательства

  • Устройство Endovascular Thrombectomy
    Patients will undergo endovascular thrombectomy plus medical management. Patients will be treated with the Penumbra System Reperfusion Catheters. Perioperative and postoperative management will follow established guidelines for the care of stroke patients.
  • Другое Medical Management
    All medical management treatment will follow established guidelines for the care of stroke patients. All medical treatments and supportive care will be administered following each participating hospital's routine practice and in accordance with the Instructions for Use for any medication administered.

Первичные конечные точки

  • Change in NIHSS at 24 hours [Срок оценки: 24 hours]
Вторичные конечные точки (8)
  • 90-day Modified Rankin Scale (mRS) [Срок оценки: 90 Days]
  • Reperfusion measures, quantified as proportion of participants with a final mTICI 2b or higher after all treatment [Срок оценки: Treatment/Procedure]
  • 90-day NIHSS [Срок оценки: 90 Days]
  • Quality of Life, as measured by Barthel Index [Срок оценки: 90 Days]
  • Quality of Life, as measured by Neuro-QoL [Срок оценки: 90 Days]
  • Quality of Life, as measured by Canadian Outcome Scale for Minor Stroke (COSMOS) [Срок оценки: 90 Days]
  • Safety events of interest [Срок оценки: Treatment, Procedure (if applicable), 24 Hours, Discharge and/or 7 Days, 90 Days]
  • Treatment method per the physician's clinical judgment [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • Participant age ≥ 18
  • Participant experiencing acute ischemic stroke due to a confirmed primary M2 occlusion in the vertical segment or post-bifurcation in the non-dominant or co-dominant branch of the horizontal segment
  • NIHSS ≥5 or NIHSS 3-4 with disabling symptoms
  • Pre-stroke mRS 0-1
  • For participants undergoing thrombectomy: Planned first-line treatment with Penumbra System reperfusion catheters
  • Informed consent obtained per Institutional Review Board/Ethics Committee requirements

Критерии исключения

  • Any stenosis or occlusion in the ICA origin requiring treatment during the procedure or within the 90-day follow-up period.
  • Known multiple occlusions
  • Secondary M2 occlusion
  • Known or high suspicion of underlying ICAD as the cause of the M2 occlusion
  • Current hospitalization at time of stroke onset and/or any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days
  • Currently participating in an investigational (drug, device, etc.) clinical trial that will influence the endovascular procedure or acute treatment. Participants in secondary prevention, observational, natural history and/or epidemiological studies are eligible.
  • Other medical, behavioral, or psychological conditions that in the opinion of the Investigator could limit the ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study

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 · 1 центр
  • Fort Sanders Regional Medical Center — Knoxville

Идентификаторы

NCT: NCT07749170 · 33727

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗