Real-World Study of Woven EndoBridge for Intracranial Aneurysm Treatment
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: Intrasaccular Flow Disruption Device.
- Кому может быть актуально
- Состояния в реестре: Intracranial Aneurysm. Базовые параметры: Без ограничений · 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Real-World Study of Intrasaccular Flow Disruption Devices for the Treatment of Intracranial Aneurysms
Обзор
We designed the Real-World Study of Woven EndoBridge for Intracranial Aneurysm Treatment (WEB-RWS), an ambidirectional, multicenter, post-market real-world study with a prospective active surveillance component. The study will include patients with IAs treated with commercially available WEB devices under the direction of treating physicians in routine clinical practice. Clinical, procedural, imaging, and safety data will be collected using a standardized electronic data capture system, with safety events adjudicated by an independent clinical events committee and imaging outcomes assessed by an independent core laboratory. The primary objective is to evaluate 12-month adequate aneurysm occlusion and major adverse events after WEB treatment. The study is expected to provide comprehensive post-market evidence on the real-world performance of the WEB device in China, including its safety, effectiveness, clinical appropriateness, and health economic value in routine neurointerventional practice.
Подробное описание
Intracranial aneurysms are abnormal dilatations of blood vessels in the brain. If an aneurysm ruptures, it can cause subarachnoid hemorrhage, which may lead to serious disability or death. Endovascular treatment has become an important treatment option for intracranial aneurysms. The Woven EndoBridge (WEB) device is an intrasaccular flow disruption device designed to treat selected intracranial aneurysms from within the aneurysm sac.
This study is a post-market, ambispective, multicenter, real-world registry study. It will evaluate the safety and performance of commercially available MicroVention WEB devices when used by treating physicians according to routine clinical practice and the approved instructions for use. The study does not assign participants to a treatment group and does not require a randomized comparison. Treatment decisions are made by the treating physicians based on standard medical care.
The study plans to enroll up to 1,000 patients from multiple study centers in China. Approximately 200 patients will be included retrospectively, and approximately 800 patients will be included prospectively. Eligible participants are patients with intracranial aneurysms treated with a commercially available WEB device. For the prospective cohort, written informed consent will be obtained from the participant or legally authorized representative before study-related data collection, as applicable.
Clinical data will be collected using an electronic data capture system. Imaging data will be de-identified and submitted for independent core laboratory assessment. Follow-up assessments are planned after the procedure and at approximately 30 days, 6 months, and 12 months. Follow-up may include neurological assessment, imaging evaluation, information on aneurysm retreatment, adverse event assessment, serious adverse event assessment, and information on antiplatelet or anticoagulant medication use.
The primary effectiveness outcome is the proportion of aneurysms with adequate occlusion at 12 months, based on the Raymond-Roy Occlusion Classification. Adequate occlusion is defined as Raymond-Roy class I or II. The primary safety outcome is the rate of major adverse events, including unexpected death or major stroke within 30 days after the procedure, and neurological death or major stroke from 31 days to 1 year after the procedure.
Other outcomes include aneurysm occlusion based on the WEB Occlusion Scale, aneurysm recurrence, aneurysm retreatment, rebleeding, parent artery patency, clinical outcome measured by the modified Rankin Scale, device-related serious adverse events, procedure-related serious adverse events, neurological events, successful device implantation and health economic outcomes. The study will mainly use descriptive statistical methods to summarize outcomes and confidence intervals.
Вмешательства
- Устройство Intrasaccular Flow Disruption Device
The intervention of interest is treatment of intracranial aneurysms using the commercially available MicroVention Woven EndoBridge device. The device is an intrasaccular flow disruption device used during endovascular treatment according to routine clinical practice and the approved instructions for use. Treatment decisions and procedural details are determined by the treating physician.
Первичные конечные точки
- Incidence of Major Adverse Events [Срок оценки: Up to 1 Year After the Index Procedure]
- Proportion of Aneurysms With Adequate Occlusion Based on Raymond-Roy Occlusion Classification [Срок оценки: 12 Months After the Index Procedure]
Вторичные конечные точки (12)
- Proportion of Aneurysms With Adequate Occlusion Based on WEB Occlusion Scale [Срок оценки: 12 Months After the Index Procedure]
- Aneurysm Occlusion Status Based on Raymond-Roy Occlusion Classification and WEB Occlusion Scale [Срок оценки: 12 Months After the Index Procedure]
- Aneurysm Occlusion Without Rebleeding in Ruptured Aneurysms [Срок оценки: 12 Months After the Index Procedure]
- Aneurysm Occlusion Without Rebleeding or Retreatment in Aneurysms With Residual Filling [Срок оценки: 12 Months After the Index Procedure]
- Stability of Aneurysm Occlusion [Срок оценки: From 6 Months to 12 Months After the Index Procedure]
- Aneurysm Recurrence [Срок оценки: Up to 1 Year After the Index Procedure]
- Aneurysm Retreatment [Срок оценки: Up to 1 Year After the Index Procedure]
- Unplanned Retreatment or Alternative Treatment [Срок оценки: Up to 1 Year After the Index Procedure]
- Rebleeding Within 30 Days in Ruptured Aneurysms [Срок оценки: Up to 30 Days After the Index Procedure]
- Rebleeding Within 1 Year in Ruptured Aneurysms [Срок оценки: Up to 1 Year After the Index Procedure]
- New Bleeding of the Target Aneurysm in Unruptured Aneurysms [Срок оценки: Up to 1 Year After the Index Procedure]
- Parent Artery Patency [Срок оценки: 12 Months After the Index Procedure]
Критерии участия
Критерии включения
Retrospective Cohort:
- Participants of any age and sex.
- Patients treated for an intracranial aneurysm using a commercially available MicroVention Woven EndoBridge device.
- Patients who completed at least one postoperative imaging follow-up.
Prospective Cohort:
- Participants of any age and sex.
- Patients treated for an intracranial aneurysm using a commercially available MicroVention Woven EndoBridge device.
- The participant, or legally authorized representative if applicable, understands the study requirements and procedures and provides written informed consent before any study-specific data collection.
Критерии исключения
Retrospective Cohort:
- Patients treated with a Woven EndoBridge device for whom intraoperative or postoperative follow-up imaging data are not available.
- Patients considered by the investigator to be unsuitable for participation in this study.
Prospective Cohort:
- Participants who are currently participating in, or plan to participate during the follow-up period, another clinical study that may affect the results of this study.
- Patients who are currently unable or expected to be unable to complete follow-up.
- Patients with a life expectancy of less than 1 year due to other diseases or conditions.
- Patients considered by the investigator to be unsuitable for participation in this 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
Китай · 1 центр
- Xuanwu Hospital — Пекин
Идентификаторы
NCT: NCT07620626 · xwzhqsxwsmhyf