Evaluation of the Castor Single Branch Stent Graft in Treatment of Acute Aortic Syndrome
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: the Castor single branch stent graft.
- Кому может быть актуально
- Состояния в реестре: Acute Aortic Syndrome. Базовые параметры: 18 лет — 95 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Real-world Experience With the Castor Single Branch Stent Graft in the Management of Acute Aortic Syndrome
Обзор
The objective of this study to evaluate the safety and effectiveness of the Castor single branch stent graft for endovascular repair of acute aortic syndrome patients without an inadequate proximal landing zone (\<15mm)
Подробное описание
The goal of this observational, ambispective, and multicenter cohort study is to evaluate efficacy and safety of the Castor single branch stent graft.
205 patients who received thoracic endovascular aortic repair by meant of the Castor single branch stent graft from June 2018 to June 2022 were enrolled in our study. All enrolled patients have an inadequate proximal landing zone (\<15mm) , and they underwent routine follow-up after thoracic endovascular aortic repair at 1-month, 6-months, and 1-year for the following, but not limited to assessment: physical examination, laboratory test and the CT angiography.
Meanwhile, the enrolled patients will come for continuous follow-up at 2-years, 3-years, and annually to 10-years post-procedure.
Вмешательства
- Устройство the Castor single branch stent graft
Participants who received thoracic endovascular aortic repair by meant of the Castor single branch stent graft from June 2018 to June 2022 were enrolled in our study.
Первичные конечные точки
- Immediate post-operative technique success [Срок оценки: immediately post operation]
- All-cause mortality and major [Срок оценки: 1-year post operation]
Вторичные конечные точки (3)
- Major device/procedure-related adverse events of post-operation as assessed by computer tomography angiography [Срок оценки: 1-month, 6-months, 1-year, and annually to 10-years post operation]
- Aortic remodeling results as assessed by computer tomography angiography (the size of the true and false lumen of aorta, and the thrombosis degree of the false lumen of aorta) [Срок оценки: 1-month, 6-months, 1-year, and annually to 10-years post operation]
- Re-intervention during follow-up [Срок оценки: 1-month, 6-months, 1-year, and annually to 10-years post operation]
Критерии участия
Критерии включения
- Patients with acute Stanford type B aortic syndrome who received thoracic endovascular aortic repair by meant of Castor single branch stent graft from June 2018 to June 2022
Критерии исключения
- Patients with acute type B aortic syndrome with an adequate proximal landing zone (≥15mm)
- Previous endovascular repair of the aorta
- Patients with missing data and loss of follow-up
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
- First Affiliated Hospital of Xi'an Jiaotong University — Сиань
Идентификаторы
NCT: NCT05965453 · No.XJTU1AF2023LSK-148