NEXUS™ Aortic Arch Stent Graft System Data Collection Study for Compassionate-Use Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Performance Evaluation Criteria
研究概览
简要总结
A Multicenter, observational Data Collection Study to Evaluate the Safety and Performance of the Nexus™ Aortic Arch Stent Graft System in patients that were implanted with the device as part of Compassionate Use Procedures.
详细描述
The purpose of the study is to collect and analyze data that is recorded as standard of care for patients that were implanted with the Nexus device as part of Compassionate Use Procedures.The data will be used to obtain additional information on the safety and performance of the Nexus™ Aortic Arch Stent Graft System in patients affected by pathologies involving the aortic arch.
Data will be collected at each time point of patient's follow up conducted according to the standard of care in each site.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 for whom the Nexus implantation was initiated as part of a compassionate use procedure.
- •A signed and dated Informed Consent document is available that authorizes to collect the patient's personal data following implantation of the Nexus systems and throughout the follow ups visits up to 5 years following implantation.
排除标准
- •There are no exclusions. Data will be collected for all implanted population as described in the inclusion section above
结局指标
主要结局
Performance Evaluation Criteria
时间窗: within 30 days post implantation
Successful disease treatment at 30 days post implantation, defined as Stent Graft positioned in the aortic arch isolating the diseased lesion based on review of medical charts by the Investigators.
Primary Safety Evaluation Criteria
时间窗: within 30 days post implantation
Device related mortality at 30 days post implantation based on review of medical charts by the Investigators
次要结局
- Secondary Safety Evaluation Criteria(within 1 year post-implantation)