SEAL - Safety & Feasibility Evaluation of the Aortoseal™ for Seal and Fixation of Abdominal Aortic Aneurysms (AAA) Endovascular Grafts to the Aortic Wall"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Rate of Major Adverse Events
研究概览
简要总结
The Aortoseal Endostapling System is indicated in patients undergoing, or having undergone, treatment of an abdominal aortic aneurysm (AAA) with an endovascular graft to provide enhanced fixation and apposition to the aorta.
详细描述
The device may be implanted at the time of the initial endovascular graft procedure to maintain, or during a secondary procedure to restore, adequate aneurysm.
The study includes 5 years of follow-up, with visits at 30 days, 6 months, 1 year, and yearly thereafter through 5-years.
Follow-up assessments: Physical examination, X-ray, CT (with and without contrast) and assessments of any adverse events.
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
- •Subjects diagnosed with a qualifying AAA suitable for elective endovascular repair with Endovascular Graft System or have a previously placed endovascular graft.
排除标准
- 未提供
研究组 & 干预措施
Aortoseal Endostapling System
Prospective, early feasibility, non-randomized, single arm, multi-center, open-label clinical study
干预措施: Aortoseal Endostapling System (Device)
结局指标
主要结局
Rate of Major Adverse Events
时间窗: through 5 years
The EFS does not have defined primary endpoints nor any powered endpoints. The SEAL Study is not hypothesis driven. All endpoints will be analyzed descriptively
Access Site Complications
时间窗: through 30 days
The EFS does not have defined primary endpoints nor any powered endpoints. The SEAL Study is not hypothesis driven. All endpoints will be analyzed descriptively
All Adverse Events
时间窗: through 5 years
The EFS does not have defined primary endpoints nor any powered endpoints. The SEAL Study is not hypothesis driven. All endpoints will be analyzed descriptively
Endpoints related to Aortoseal Endostapling System
时间窗: through 5 years
The EFS does not have defined primary endpoints nor any powered endpoints. The SEAL Study is not hypothesis driven. All endpoints will be analyzed descriptively
Device Technical Success
时间窗: during procedure
The EFS does not have defined primary endpoints nor any powered endpoints. The SEAL Study is not hypothesis driven. All endpoints will be analyzed descriptively
次要结局
未报告次要终点