Multicenter, Observational, Post-Market, Real World Registry to Assess Outcomes of Patients Treated With the 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
- 300
- 试验地点
- 38
- 主要终点
- Immediate procedural technical success
研究概览
简要总结
This registry has been designed as a multicenter, single arm, open label, post-market 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 up to discharge discharge, and as per institutional standard of care thereafter through to 5 years (total follow-up commitment). This registry of the Nellix System, which has received the market authorization of the European Union (Conformité Européenne, CE-certification) in a "real world" patient population treated in a multicenter setting will provide an assessment of the generalizability of the approach and System.
Up to 300 patients diagnosed with abdominal aortic aneurysm (AAA) who are considered candidates for Endovascular Repair, in up to 30 international centers will be enrolled in the study.
详细描述
- Baseline: medical history, physical exams, CT image, bloodwork,
- Procedure: implantation information
- Discharge: Physical exam, bloodwork and adverse events, if any
- Follow-up according to institutional standard through to 5 years including Physical exam, CT image or standard of care imaging eg Doppler Ultrasound, bloodwork and adverse events, if any
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 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
Immediate procedural technical success
时间窗: Procedure
Number of subjects where immediate procedural technical success during procedure was noted
Peri-operative Safety Parameters
时间窗: Up to 30 days
Number of subjects with procedural Blood loss \>1000mL, Mortality (all-cause), Bowel Ischemia, Paraplegia, Renal Failure, Myocardial Infarction, Respiratory Failure, Stroke
Clinical outcome
时间窗: Up to 5 years
Number of subjects with Aneurysm rupture, Conversion to open surgical repair, Endoleak of any type, Clinically significant migration, Aneurysm enlargement through to five years, Secondary endovascular procedures of any type through to five years, Secondary endovascular procedures for (resolution of Endoleak of any type; Device occlusion (due to thrombus or other causes); Device migration AAA sac expansion (\>5mm diameter increase); Device defect)
次要结局
未报告次要终点