Early Complications After Flow Diverter Versus Stent-Assisted Coiling for Unruptured Wide-Neck Intracranial Bifurcation Aneurysms (FD-SAC BAS)
4 августа 2026 г. обновлено: Feng wen feng, Nanfang Hospital, Southern Medical University
Early Complications After Flow Diverter Versus Stent-Assisted Coiling for Unruptured Wide-Neck Intracranial Bifurcation Aneurysms: A Prospective Real-World Cohort Study
This prospective real-world cohort study aims to compare early postoperative complications between flow diverter treatment and stent-assisted coiling in patients with unruptured wide-neck intracranial bifurcation aneurysms.
A total of 274 patients from three centers in China will be enrolled and assigned to the flow diverter group or the stent-assisted coiling group according to the treatment received in routine clinical practice.
The primary outcome is a composite of any stroke or all-cause death within 30 days after the procedure.
The study will also collect demographic, clinical, laboratory, imaging, aneurysm morphological, procedural, and follow-up data to evaluate the safety of these two endovascular treatment strategies in a real-world setting.
Обзор исследования
Статус
Рекрутинг
Условия
Вмешательство/лечение
Подробное описание
Intracranial bifurcation aneurysms are common and are challenging to treat because of their complex anatomy. Flow diverters have emerged as an innovative endovascular therapy and have shown preliminary efficacy in bifurcation aneurysms. However, compared with conventional stent-assisted coiling, real-world evidence regarding early postoperative complication risks and related influencing factors remains limited.
This study will establish a prospective multicenter real-world database to compare the incidence of early complications after treatment with a flow diverter versus stent-assisted coiling in patients with unruptured wide-neck intracranial bifurcation aneurysms. Eligible patients who provide informed consent and meet the inclusion and exclusion criteria will be enrolled from three centers in China. Patients treated with a flow diverter will enter the flow diverter group, and patients treated with stent-assisted coiling will enter the stent-assisted coiling group.
All patients will undergo preoperative evaluation, perioperative management, postoperative antiplatelet therapy, and follow-up according to clinical practice and relevant guidelines. Data collected will include demographic characteristics, medical history, physical examination, laboratory tests, imaging findings, aneurysm morphology, procedural details, device information, medication history, and adverse events. Follow-up will be performed at 30 days after treatment to assess safety outcomes.
Тип исследования
Наблюдательный
Регистрация (Оцененный)
274
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Huibin Kang Study Contact, MD
- Номер телефона: 13520296286
- Электронная почта: kanghuibindoctor@163.com
Места учебы
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Guangzhou, Китай
- Рекрутинг
- Zhujiang Hospital, Southern Medical University
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Контакт:
- Xin Feng, Principal Investigator
- Электронная почта: 11111111@163.com
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Guangzhou, Китай
- Рекрутинг
- Guangdong Province People's Hospital
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Контакт:
- Shengpan Chen, MD
- Электронная почта: 19801168712@163.com
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Guangdong
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Guangzhou, Guangdong, Китай
- Рекрутинг
- Nanfang Hospital, Southern Medical University
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Контакт:
- Wenfeng Feng Feng, Principal Investigator, MD
- Номер телефона: 13501509911
- Электронная почта: fengwf1967@163.com
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Метод выборки
Невероятностная выборка
Исследуемая популяция
Patients aged 18 to 75 years with unruptured, saccular, wide-neck intracranial bifurcation aneurysms diagnosed by CTA, MRA, or DSA who meet the clinical indications for endovascular treatment and are treated at participating centers.
Eligible patients must provide written informed consent and will receive either flow diverter treatment or stent-assisted coiling according to the study protocol.
Описание
Inclusion Criteria:
- Voluntarily provides written informed consent.
- Aged 18 to 75 years.
- Diagnosed by CTA, MRA, or DSA as having an unruptured, bifurcation, saccular, wide-neck intracranial aneurysm.
- Able to understand the purpose of the study.
Exclusion Criteria:
- Patients with two or more multiple aneurysms, all of which require treatment within 1 year.
- Patients with other cerebrovascular diseases such as arteriovenous malformation or moyamoya disease.
- Patients with ruptured aneurysms or narrow-neck aneurysms.
- Patients who experienced stroke, including cerebral hemorrhage or cerebral infarction, within the past 1 month.
- Patients with poor clinical condition, defined as modified Rankin Scale score ≥3.
- Patients who have already planned to undergo surgical or interventional treatment within 3 months.
- Patients considered by the investigator to be unsuitable for endovascular treatment, such as those with no suitable vascular access, excessively tortuous vessels, or difficulty in stent delivery.
- Patients unsuitable for anesthesia or endovascular treatment, including those with major heart, lung, liver, spleen, or kidney disease, brain tumor, severe active infection, disseminated intravascular coagulation, or a history of severe psychiatric disorder.
- Patients unable to receive antiplatelet or anticoagulant therapy.
- Patients with a previous or possible severe reaction to contrast agents that would prevent completion of pre-treatment medication or treatment.
- Patients with a known history of allergy to cobalt-chromium or nickel-titanium alloy materials.
- Patients who participated in another drug or medical device clinical trial before enrollment and have not reached the time point of the primary endpoint.
- Pregnant or lactating women.
- Patients with life expectancy less than 12 months.
- Patients judged by the investigator to have poor compliance and inability to complete the study as required
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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Flow Diverter Group
Patients with unruptured wide-neck intracranial bifurcation aneurysms who receive flow diverter treatment in routine clinical practice.
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Flow diverter treatment will be performed according to routine clinical practice and relevant guidelines.
A flow-diverting stent will be deployed to cover the aneurysm neck after angiographic evaluation and device sizing.
Perioperative management and antiplatelet therapy will be performed according to the study protocol and clinical practice.
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Stent-Assisted Coiling Group
Patients with unruptured wide-neck intracranial bifurcation aneurysms who receive stent-assisted coiling in routine clinical practice.
|
Stent-assisted coiling will be performed according to routine clinical practice and relevant guidelines.
A stent will be deployed across the aneurysm neck, followed by coil embolization of the aneurysm.
Perioperative management and antiplatelet therapy will be performed according to the study protocol and clinical practice.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Composite incidence of any stroke or all-cause death within 30 days after procedure
Временное ограничение: Within 30 days after procedure
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The primary outcome is the occurrence of any stroke or all-cause death within 30 days after the endovascular procedure.
Stroke is defined as an acute onset of focal or global neurological dysfunction caused by vascular injury of the brain, spinal cord, or retina due to hemorrhage or infarction, with symptoms lasting 24 hours or longer.
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Within 30 days after procedure
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Incidence of any stroke within 30 days after procedure
Временное ограничение: Within 30 days after procedure
|
Incidence of any ischemic or hemorrhagic stroke within 30 days after the procedure.
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Within 30 days after procedure
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Incidence of transient ischemic attack within 30 days after procedure
Временное ограничение: Within 30 days after procedure
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Incidence of transient ischemic attack within 30 days after the procedure.
Transient ischemic attack is defined as a transient episode of focal neurological dysfunction caused by ischemia of the brain, spinal cord, or retina, with symptoms lasting less than 24 hours and without acute infarction.
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Within 30 days after procedure
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Incidence of all-cause death within 30 days after procedure
Временное ограничение: Within 30 days after procedure
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Incidence of death from any cause within 30 days after the procedure.
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Within 30 days after procedure
|
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Incidence of adverse events and serious adverse events within 30 days after procedure
Временное ограничение: Within 30 days after procedure
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Incidence of adverse events and serious adverse events recorded during the perioperative period and follow-up period.
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Within 30 days after procedure
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Wenfeng Feng, MD, Nanfang Hospital, Southern Medical University
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
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Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
19 марта 2026 г.
Первичное завершение (Оцененный)
19 марта 2027 г.
Завершение исследования (Оцененный)
19 марта 2028 г.
Даты регистрации исследования
Первый отправленный
4 августа 2026 г.
Впервые представлено, что соответствует критериям контроля качества
4 августа 2026 г.
Первый опубликованный (Действительный)
10 августа 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
10 августа 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
4 августа 2026 г.
Последняя проверка
1 августа 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2026STI341 (Идентификатор реестра: National Engineering Research Center of Science and Technology Information STI Digital Health Laboratory)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕ РЕШЕНО
Описание плана IPD
The individual participant data sharing plan has not yet been determined and will be decided according to institutional policy, ethics committee requirements, and participant privacy considerations.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .