Multicenter, Observational, Registry to Assess Outcomes of Patients Treated With the CE Marked Nellix® System for Endovascular Abdominal Aortic Aneurysm Repair"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Endologix
- 入组人数
- 48
- 试验地点
- 19
- 主要终点
- Number of subjects with Immediate Procedural Technical Success
研究概览
简要总结
Multicenter, single arm, open label, registry study with consecutive, eligible patient enrollment at each site. All subjects undergoing the Endovascular Aneurysm Sealing System (EVAS) with the Nellix®-System. Subjects will be followed procedurally to discharge, and as per institutional standard of care thereafter through to 5 years (total follow-up commitment)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female at least 18 years old
- •Subject has signed informed consent for data release
- •Subjects with with AAA and eligible for endovascular repair
排除标准
- •Currently participating in another study where primary endpoint has not been reached yet
- •Known allergy to any of the device components
- •Pregnant (females of childbearing potential only)
结局指标
主要结局
Number of subjects with Immediate Procedural Technical Success
时间窗: 30 Days
Technical success is defined as successful delivery and deployment of the Nellix System in the planned location.
Number of subjects with Conversion to open surgical repair
时间窗: 5 years
The number of patients undergoing surgical conversion to open repair will be provided at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5).
Number of subjects with Clinically significant migration
时间窗: 5 years
The number of patients with clinically significant migration will be summarized descriptively.
Number of incidence with Secondary endovascular procedures
时间窗: 5 years
The overall secondary procedure incidence and the individual component incidence will be provided.
Number of subjects with Aneurysm rupture
时间窗: 5 years
The number of patients experiencing a rupture of the aneurysm will be summarized at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5).
Number of subjects with Aneurysm enlargement
时间窗: 5 years
The number of patients with Aneurysm enlargement will be summarized descriptively. Sac enlargement is defined in the protocol as increase in late follow-up compared to the initial post-op measurement.
Number of subjects with Endoleak of any type
时间窗: 5 years
The number of patients with any endoleak, and patients with each endoleak type at 30 days and within each follow-up window (i.e., six months, and annually at years 1 through 5) will be summarized.
Safety assessment by Number of subjects with absence of Major Adverse Events (MAEs)
时间窗: 30 Days
Safety endpoint is measured with the number of subjects who are reported freedom of major adverse events (MAEs) including (1) all-cause death, (2) bowel ischemia, (3) myocardial infarction, (4) paraplegia, (5) renal failure, (6) respiratory failure, (7) stroke, and (8) Blood Loss \> 1000mL at 30 Days post index procedure.
次要结局
未报告次要终点