Efficacy Superiority of Angio-Seal™ vs. Manual Compression in Interventional Radiology
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 123
- 试验地点
- 4
- 主要终点
- Number of Patients With Mobilization Time Between 0-4 Hours
研究概览
简要总结
Clinical study in patients undergoing any intervention requiring vascular access to the femoral artery. The study compares Angio-Seal™ vs. Manual Compression with regard to control the vascular access.
It is designed to demonstrate superiority of the Angio-Seal™ with an unchanged risk-profile.
详细描述
Patients will have their puncture closure randomly performed by one of these approved methods: Angio-Seal™ Closure device or Manual Compression.
Patients will be enrolled in the study during 12 months, with a follow-up period of 2 weeks (± 1 week).
The randomization will be stratified according to the type of procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient ≥ 18 years Interventional Radiology procedures with Femoral Artery puncture (4 French - 8 French Introducers)
- •Patient available for follow-up at 2 weeks
- •Patients who are willing to participate and have signed an Ethic Committee approved patient informed consent.
排除标准
- •Access unsuitable for use of Angio-Sea
- •Presence of calcification at the puncture site
- •Presence of visible hematoma at the end of the procedure
- •Patients who are unable to comply with the follow-up schedule based on their geographic location or for any reason.
- •Patients who are pregnant.
- •Patients currently participating in a clinical investigation that includes an active treatment arm.
- •Contraindication for ambulation at 2 hours after the end of the procedure
- •Patients with a life expectancy of less then 1 month.
研究组 & 干预措施
Angio-Seal
Closure procedure by Angio-Seal
干预措施: Angio-Seal (Device)
Manual compression
Closure procedure by manual compression
干预措施: Manual compression (Procedure)
结局指标
主要结局
Number of Patients With Mobilization Time Between 0-4 Hours
时间窗: At discharge
Mobilization Time is the time that patient gets the authorization to flex the leg, sit or walk.
次要结局
- Time to Discharge From Interventional Radiology Department(At discharge)
- Number of Patients With Mobilization Time Between 4-48 Hours(At discharge)
- Number of Patients With Any Complications(At puncture closure procedure, at discharge and at follow up (2 weeks+/-1 week))
- Number of Patients With Time to Hemostasis Between 0-4 Minutes(At puncture closure)
- Number of Patients With Time to Hemostasis Between 4-60 Minutes(At puncture closure)
- Percentage of Patients With Angio-Seal™ Deployment Success(At puncture closure)