NCT01977508终止不适用
The Vascutek Rapidax™ II Post Market Surveillance Registry
Vascutek Ltd.3 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2013年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Safety and Performance
研究概览
简要总结
Multicentre, prospective, observational post-market registry. To monitor and collect data on the post-market clinical safety and performance of the Vascutek Rapidax II Vascular Access Graft.
详细描述
At least 10 patients who have been implanted with a Rapidax II Vascular Access Graft for haemodialysis applications in patients with End Stage Renal Disease (ESRD), who are undergoing or are scheduled to begin haemodialysis and require implant of a prosthetic graft.
Primary End Points:Safety and Performance
- Secondary patency at 6 months post implant (Performance).(access survival until abandonment). The interval from time of implant to abandonment or time of measurement of patency, including intervention to re-establish the functionality of the thrombosed access
- Secondary patency at 12 months post implant (Performance.(access survival until abandonment). The interval from time of implant to abandonment or time of measurement of patency, including intervention to re-establish the functionality of the thrombosed access
- Freedom from device related Serious Adverse Events at 6 and 12 months (Safety)
Secondary End Points: Safety and performance
- Primary patency at 6 months post implant (Performance. (intervention free access survival). The interval from time of implant to any intervention designed to maintain or re-establish patency or to access thrombosis
- Primary patency at 12 months post implant (Performance).(intervention free access survival). The interval from time of implant to any intervention designed to maintain or re-establish patency or to access thrombosis
- Assisted primary patency at 6 months (Performance. (thrombosis free access survival). The interval from time of implant to intervention to maintain patency prior to the occurrence of thrombosis
- Freedom from device related Serious Adverse Events at 6 and 12 months
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subject is ≥ 18 and ≤ 90 years old
- •Subject has a life expectancy of at least 12 months
- •Subject is scheduled to undergo placement of a new straight or loop arm arteriovenous haemodialysis access graft
- •The subject is willing and able to comply with the protocol and associated follow up requirements
- •Subjects must have agreed for their data to be entered into the registry as per the local hospital consent procedure
排除标准
- •Known allergy or sensitivity to ePTFE
- •Subject unwilling or unable to comply with the protocol
- •Life expectancy of less than 1 year
结局指标
主要结局
Safety and Performance
时间窗: 12 months
Freedom from device related Serious Adverse Events at 6 and 12 months (Safety)
次要结局
- Safety and Performance(12 months)
研究者
研究点 (3)
Loading locations...
相似试验
终止
不适用
Vascutek Anaconda™ Abdominal Aortic Aneurysm (AAA) Post-Market Surveillance RegistryAbdominal Aortic AneurysmNCT01744119Vascutek Ltd.318
Unknown
不适用
Medigus Ultrasonic Surgical Endostapler (MUSE) RegistryGastroesophageal Reflux Disease (GERD)NCT02366169Medigus Ltd200
终止
不适用
The Vascutek Custom Fenestrated Anaconda Post-Market Surveillance StudyAbdominal Aortic Aneurysms (AAA)NCT01826344Vascutek Ltd.628
终止
不适用
Post Market Observational, Prospective, Multi-center StudyEmphysemaNCT01806636Boston Scientific Corporation1,275
已完成
不适用
The VIRTUE Post Marketing Surveillance RegistryAortic DissectionNCT01213589Medtronic Endovascular100