Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption (IDE) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Endologix
- 入组人数
- 75
- 试验地点
- 13
- 主要终点
- Number of Subjects With Treatment Success
研究概览
简要总结
A prospective clinical evaluation of the effectiveness of the Ovation Alto Abdominal Stent Graft System when used in the treatment of subjects with abdominal aortic aneurysm (AAA).
详细描述
A prospective clinical evaluation of the effectiveness of the Ovation Alto Abdominal Stent Graft System when used in the treatment of subjects with abdominal aortic aneurysm (AAA). The primary objective is to evaluate treatment success at 12 months with the Ovation Alto Abdominal Stent Graft system. The study will have up to 16 sites, and up to 75 patients based on attrition rates. The follow-up intervals will be at 1, 6, and 12 months following initial implant procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient has adequate iliac/femoral access compatible with the required delivery systems.
- •Patient has non-aneurysmal proximal aortic neck.
- •Patient has non-aneurysmal distal iliac landing zone.
排除标准
- •Patient has dissecting aneurysm.
- •Patient has acutely ruptured aneurysm.
- •Patient has need for emergent surgery.
研究组 & 干预措施
Ovation Alto Abdominal Stent Graft System
Endovascular repair of AAA using the Ovation Alto Abdominal Stent Graft System.
干预措施: Ovation Alto Abdominal Stent Graft System (Device)
结局指标
主要结局
Number of Subjects With Treatment Success
时间窗: 12 months
Treatment success is defined as technical success, freedom from type I and III endoleaks at 12 months, freedom from stent graft migration \> 10m at 12 months compared to 1 month baseline, freedom from AAA enlargement \>5mm at 12 months (compared to 1-month baseline, freedom from AAA rupture through 12 months, freedom from conversion to open repair through 12 months, stent graft stenosis, occlusion or kink requiring secondary intervention through 12 months, thromboembolic event attributable to stent graft requiring secondary intervention through 12 months, stent fracture requiring secondary intervention through 12 months.
次要结局
- Number of Secondary Interventions(30 days, Day 31-365)
- Number of Participants With AAA Enlargement > 5mm(6 months, 12 months)
- Number of Participants With Conversion to Open Repair(30 day, Day 31-365)
- Number of Participants With AAA-related Mortality(1 month, Day 31-365)
- Major Adverse Events(1 year)
- Number of Participants With Other Stent Graft Finding (Includes Kinking and Stent Compression)(1 month, 6 months, 12 months)
- Number of Participants With Stent Fracture(1 month, 6 months, 12 months)
- Adverse Events (Serious and Non-serious)(30 days, Day 31-365)
- Event Rates for Endoleaks(1 month, 6 months, 12 months)
- Number of Participants With Stent Graft Migration > 10mm(6 months, 12 months)
- Number of Participants With AAA Rupture(30 day, Day 31-365)
- Device-related Adverse Events (AEs)(30 days, Day 31-365)
- Procedure-related Adverse Event(30 days, Day 31-365)
- Serious Adverse Event(30 Days, Day31-365))