National Registry of Lumen Apossing Metal Stent Incidences
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 413
- 试验地点
- 1
- 主要终点
- Describe the type and proportion of complications that arise from the Axios apposition luminal prosthesis, through study completion, an average of 1 year
研究概览
简要总结
Study design: Prospective Case Series Disease or disorder under study: Lifespan of the Axios apposition luminal prosthesis Population under study: Patients with an Axios type intraluminal apposition prosthesis
Expected dates of completion:
- Start: January 2019
- Completion: December 2020 Funding source: Does not require financing
详细描述
Hypothesis:
The presence of events or incidents in the follow-up and the subsequent removal of the Axios type luminal apposition prosthesis is not related to the patent time and the indication
Design:
Prospective Case Series
Methods:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 in whom at least the initial puncture of the access organ wall is achieved for the transmural placement of an Axios type PAL
排除标准
- •Refusal to sign the informed consent.
- •Inability to track
结局指标
主要结局
Describe the type and proportion of complications that arise from the Axios apposition luminal prosthesis, through study completion, an average of 1 year
时间窗: Through study completion, an average of 1 year
Describe the type and proportion of complications that arise from the Axios apposition luminal prosthesis, through study completion, an average of 1 year
次要结局
未报告次要终点
研究者
Sergio Bazaga Pérez de Rozas
Principal investigator
Hospital del Río Hortega