Anatomical Feasibility of the Off-the-shelf E-nside Multibranch Stent Graft System (JOTEC GmbH, Hechingen) for Thoracoabdominal and Para-renal Aortic Aneurysms. (E-nside Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 562
- 试验地点
- 1
- 主要终点
- Multi-planar and curved reconstruction of pre-operative contrast-enhanced computed tomography scans (CTA)
研究概览
简要总结
The study was created to evaluate the theoretical anatomical feasibility of the new E-nside Multibranch Stent Graft System (JOTEC GmbH, Hechingen) in patients with thoracoabdominal and para-renal aortic aneurysms based on retrospective review of pre-operative imaging studies of the patients treated with other techniques for this pathology in the vascular Unit of San Raffaele Hospital, in the past ten years. With this study, investigators want to analyze in how many cases the new prosthesis would be usable.
E-nside Multibranch Stent Graft System (JOTEC GmbH, Hechingen) is in the pre-CE marking stage. At present, the certifying organism is evaluating the documentation for the release the CE mark certification and Declaration of Conformity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient who underwent treatment of thoracoabdominal or para-renal aortic aneurysm at San Raffaele Hospital between January 2007 and January 2017.
排除标准
- •incomplete or inappropriate imaging quality defined as pre-operative CTAs with slice thickness >1-mm.
结局指标
主要结局
Multi-planar and curved reconstruction of pre-operative contrast-enhanced computed tomography scans (CTA)
时间窗: between January 2007 and January 2017
Number of patients (already treated in the Vascular Surgery Unit of San Raffaele Hospital) with anatomical characteristic for use (theoretic)of the new E-nside Multibranch Stent Graft System.
次要结局
未报告次要终点
研究者
Bertoglio Luca
Principal Investigator
IRCCS San Raffaele