NCT06990048进行中（未招募）不适用
The Long-Term EVAR Assessment and Follow-Up (LEAF) Study for the AFX2 System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Endologix
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Rates of AAA Rupture, Reintervention and Mortality
研究概览
简要总结
This is an observational, retrospective, multicenter study to evaluate the performance of the AFX2 System using real world evidence from VQI-VISION.
详细描述
Evaluate the clinical performance of the AFX2 System patients against other commercially available EVAR devices and evaluate the Type III endoleak occurrence in AFX2 System patients through 5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients implanted with the AFX2 System or the 3 most commonly used comparator devices who underwent EVAR as their first abdominal aortic aneurysm repair in the VQI EVAR registry will be included in this study.
排除标准
- •Ruptured AAA repair with the AFX2 or comparator device
- •Patients with AFX2 in AFX relining, or relined comparator grafts.
结局指标
主要结局
Rates of AAA Rupture, Reintervention and Mortality
时间窗: 5 Years
Rate of the composite of AAA rupture, aortic-related reintervention, and morality through 5 years.
Incidence of Endoleak
时间窗: 5 Years
Cummulative incidence of Type III endoleaks at 5 years.
次要结局
- Long Term Safety(10 Years)
研究者
研究点 (2)
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