Volcano Crux Vena Cava Filter Registry
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- Prevention of Pulmonary Embolism
研究概览
简要总结
The Crux Vena Cava Filter (VCF) Registry is a clinical study, sponsored by Volcano Corporation, to evaluate the short and long term performance and clinical outcomes of the Crux Vena Cava Filter System.
详细描述
The Crux VCF Registry is a non-randomized clinical study, sponsored by Volcano Corporation, to evaluate the short and long term performance and clinical outcomes of the Crux VCF System. The registry includes consecutive patients treated with the Crux VCF in a post-market (commercial) setting with data collection at the implant procedure through 2 years post implant or to filter retrieval, whichever comes first. Patients may also be enrolled (roll-in) from a previous Crux VCF implant within the previous 6 months. Follow up assessment will be performed at 6, 12 and 24 months post-implant and at the time of retrieval, if performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is >18 years of age.
- •Patient or their legally authorized representative understands the research nature of the study and is willing and capable of providing informed consent.
- •Scheduled for and receives a Crux VCF implant or;
- •Have previously had a Crux VCF implanted within the previous 6 months.
排除标准
- •Patient is scheduled for filter implant, but did not have a Crux VCF filter implanted due to anatomical exclusions or technical failures.
- •Patients unwilling or unable to comply with the protocol and provide informed consent.
- •Female patient of childbearing potential who is pregnant (she must have negative pregnancy test within the 48 hours prior to implantation and any retrieval procedure)
- •Patient is participating in another device or drug clinical trial that interferes with this protocol follow up schedule.
结局指标
主要结局
Prevention of Pulmonary Embolism
时间窗: 2 years
The primary objective is to evaluate the long term clinical outcomes of patients treated with the Crux VCF for the prevention of PE over a two year period or up to filter retrieval, whichever comes first.
次要结局
未报告次要终点