Post-operative CT Follow up Measurement After Nellix Endoprosthesis Implantation in Patients With Abdominal Aortic Aneurysms.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Changes in the infrarenal neck morphology (below the renal arteries)
研究概览
简要总结
Multicenter retrospective CT follow up after aortic aneurysm repair using Nellix Endoprosthesis.
详细描述
Rationale:
In patients with abdominal aortic aneurysms the Nellix Endoprosthesis aims to reduce post-operative complications and subsequent re-intervention rates. Using two stents covered with two polymer filled endobags used for sealing and excluding the aneurysm sac. Preliminary results show promising results in reducing these complications. The new endoprosthesis is not only different in treatment but also in follow up imaging. To date it is unknown how the stent, polymer filled endobags and aneurysm appear in CT imaging in short and long term follow up.
Objective:
To assess and describe the normal computed tomography (CT) appearance at 30 days and 1 year after implantation of the Nellix Endoprosthesis.
Study population:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who underwent endovascular abdominal aneurysm repair using the Nellix endoprosthesis
排除标准
- •No specific exclusion criteria
结局指标
主要结局
Changes in the infrarenal neck morphology (below the renal arteries)
时间窗: 1 year
Changes in the thrombus in the aneurysm sac
时间窗: 1 year
Changes in the aneurysm wall and geometry
时间窗: 1 year
Changes in the cobalt-chromium stent and their lumen
时间窗: 1 year
Changes in the polymer-filled endobags Using anonymous patient data a database will be created an securely stored. Patient consent for study participation will be attained before accessing patient files
时间窗: 1 year
次要结局
未报告次要终点
研究者
Michel Reijnen
M.D., PhD
Rijnstate Hospital