NCT06094127招募中不适用
A Post-market Clinical Follow up Study on Cook Medical Zenith® Alpha Thoracic Endovascular Grafts
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 20
- 主要终点
- Freedom from aneurysm-related mortality
研究概览
简要总结
This study aims to gather real-world clinical data demonstrating the continued safety and performance of the a marketed stent graft (Zenith® Alpha Thoracic Endovascular Graft [ZTA]) and collect longer term follow-up to better understand clinical outcomes associated with the expected lifetime of the device.
详细描述
Per local regulations, this study includes both retrospective and prospective patients. Patients can be included retrospectively if they are treated with the study device from 01 January 2019 until the study site is eligible for prospective enrollment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has been treated/was intended to be treated with ZTA according to the clinical practice from Jan 2019 until site initiation
- •The patient is willing to participate in the study and provide written informed consent for study participation or express non-objection or give written consent per local requirements prior to data collection of any data from medical records.
排除标准
- •A patient treated with a custom-made fenestrated and/or branched endovascular graft in conjunction with ZTA either during the same procedure or in a staged procedure.
- •A patient whose follow-up data collection is not possible (e.g. due to living abroad).
结局指标
主要结局
Freedom from aneurysm-related mortality
时间窗: 5 years
Death related to aneurysm
次要结局
未报告次要终点
研究者
研究点 (20)
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