NCT02485496终止不适用
SECURE - A poSt-market Registry in Patients With infrarEnal aortiC Aneurysm Undergoing endovasculaR Stenting With the New E-tegra Stent Graft System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- JOTEC GmbH
- 入组人数
- 38
- 试验地点
- 10
- 主要终点
- Rate of aneurysm rupture and aneurysm related death
研究概览
简要总结
The purpose of this study is to evaluate clinical and technical success as well as safety and feasibility of the E-tegra Stent Graft System used in endovascular treatment of infrarenal aortic aneurysm.
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
- •Patients must comply with the indications for use
- •Patient must have an infrarenal aortic aneurysm with diameter >5cm or an infrarenal aortic aneurysm with 4 to 5cm that has increased in size by 0.5cm in the last 6 months
- •Patient must be available for the appropriate follow-up times for the duration of the study
- •Patient has signed the informed consent before intervention
排除标准
- •Patients with one of the contraindications as indicated in the instructions for use
- •Patients with infectious aneurysm
- •Patients with inflammatory aneurysm
- •Patients with pseudoaneurysm
- •Patients with ruptured or traumatic aneurysm
- •Patients with suprarenal, juxtarenal, or pararenal aneurysm
- •Patients with aortic dissection
- •Patients with a reversed conical neck that is defined as a >3mm distal increase over a 15mm length
- •Patients who have a congenital degenerative Collagen disease or connective tissue disorder
- •Patients with thrombocytopenia
- •Patients with creatinine >2.4 mg/dl immediately before the Intervention
- •Patients with hyperthyreosis
- •Patients with malignancy needing chemotherapy or Radiation
- •Patients who are enrolled in another clinical study
- •Patients with life expectancy of less than 24 months
结局指标
主要结局
Rate of aneurysm rupture and aneurysm related death
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (10)
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