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Идёт набор NCT07604688

Multicenter Registry Study of Patients With Intracranial Dural Arteriovenous Fistulas in China

— Наблюдательное Intracranial Dural Arteriovenous Fistula

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.
Кому может быть актуально
Состояния в реестре: Intracranial Dural Arteriovenous Fistula. 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

Dural Arteriovenous Fistulas Registry, Evaluation, and Management Study in China (DREAM)

Обзор

This multicenter registry study aims to clarify the incidence trends of intracranial dural arteriovenous fistulas (IDAVF) and spinal dural arteriovenous fistulas (SDAVF) in China, evaluate current treatment patterns, and establish a nationwide multicenter retrospective and prospective database. The study is designed as a multicenter retrospective and prospective observational study involving more than 60 core hospitals across seven major geographic regions of China. The retrospective phase will include patients diagnosed between February 28, 2015 and February 28, 2025, while the prospective phase will enroll patients from March 1, 2025 to March 1, 2030. Eligible participants are patients diagnosed with IDAVF or SDAVF by digital subtraction angiography (DSA). The study will analyze disease incidence and temporal trends, collect baseline demographic and clinical characteristics, and evaluate treatment outcomes including obliteration rate, recurrence rate, and clinical prognosis. The crude incidence rate per 100,000 person-years during the study period will also be calculated based on Chinese census population data. The primary endpoint is the improvement rate in modified Rankin Scale (mRS) score at 6 months after treatment. Secondary endpoints include obliteration and recurrence rates on imaging follow-up at 6 months and improvement in mRS score at 12 months after treatment. Statistical analyses will be performed using SAS 9.4 software, including descriptive analyses as well as univariate and multivariate regression analyses to identify factors associated with clinical outcomes and prognosis.

Вмешательства

  • Процедура endovascular
    This is a multicenter retrospective and prospective observational registry study of patients with intracranial dural arteriovenous fistulas (IDAVF) and spinal dural arteriovenous fistulas (SDAVF) in China. No experimental intervention will be assigned as part of the study. Diagnosis, treatment selection, and follow-up will be performed according to routine clinical practice at each participating center, including microsurgery, endovascular embolization, radiosurgery, conservative management, or

Первичные конечные точки

  • Improvement in modified Rankin Scale (mRS) score at 6 months after treatment [Срок оценки: 6 months after treatment]
Вторичные конечные точки (2)
  • Angiographic obliteration and recurrence rates at 6 months after treatment [Срок оценки: 6 months after treatment]
  • Improvement in modified Rankin Scale (mRS) score at 12 months after treatment [Срок оценки: 12 months after treatment]

Критерии участия

Критерии включения

  • Patients diagnosed with intracranial dural arteriovenous fistula (IDAVF) or spinal dural arteriovenous fistula (SDAVF) by cerebral or spinal digital subtraction angiography (DSA)
  • Patients treated or evaluated at participating centers during the study period
  • Availability of complete clinical and imaging records, including baseline information, treatment records, and DSA images
  • For the prospective cohort, written informed consent signed by the patient or legal representative

Критерии исключения

  • Patients with facial or scalp arteriovenous fistulas
  • Patients with non-dural vascular malformations or non-arteriovenous fistula vascular diseases, including cavernous malformations or venous malformations

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
  • Xuanwu Hospital — Пекин

Публикации

  • Su X, Ma Y, Song Z, Liu H, Zhang C, Pang H, Chen Y, Zhao B, Huang M, Sun L, Hu P, Li G, Hong T, Ye M, Zhang H, Zhang P. Dural arteriovenous fistula research and management in China (DREAM-INI): initial characterization and patient cohort outcomes. J Neurointerv Surg. 2026 Jan 13;18(2):332-338. doi: 10.1136/jnis-2024-023014. PMID 39922696

Идентификаторы

NCT: NCT07604688 · zpmyjsx930826

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗