RAVE: Radial Artery Vascular Complication and Resource Utilization in Subjects Undergoing an Angiogram/PCI (Percutaneous Coronary Intervention)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Time to Hemostasis
研究概览
简要总结
The primary objective of this study is to determine if there is a reduction in time to hemostasis in subjects treated with SoftSeal®-STF hemostatic pad when used in conjunction with a vascular compression device after radial transcatheter procedure.
详细描述
The SoftSeal-STF hemostatic pad and compression devices (TR BAND® and RadAR EasyCLik) function to stop bleeding without obstructing radial artery flow, and have been shown to reduce the occurrence of radial artery occlusion.
The SoftSeal-STF hemostatic pad is an FDA-approved, chitosan-based, non-woven pad with a unique, proprietary fiber structure that when hydrated with tissue fluids forms a gel-like synthetic clot. Its mechanism of action is believed to be due to bioadhesion between the chitosan polymer chains, which are positively charged, and the negatively charged blood and tissue components, thereby stopping bleeding.
In this study the RadAR EasyCLik and TR BAND® Compression devices will be used with the SoftSeal®-STF hemostatic pad to promote hemostasis at the puncture site. Both vascular compression devices are FDA approved.
The VascBand™ Hemostat is an FDA-approved compression device designed to assist hemostasis of arterial, venous and hemodialysis percutaneous access sites.
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
- •Scheduled for an angiogram/PCI
- •Planned transradial approach
排除标准
- •Evidence of impaired dual perfusion to the hand when tested using Allen's test
- •Inaccessible radial arteries due to anatomic variations
- •Infection or other skin disorder at the puncture site
- •Undergoing an emergent or unplanned angiogram using the transradial approach
- •Evidence of severe cognitive impairment or inability to understand the study procedures and answer follow-up questions
- •Known sensitivity or allergic reaction to materials in the study devices
- •Unwilling to participate in the study and follow all study-related procedures
- •Participating physician deems the subject to not be a good candidate
- •Inability to achieve radial access
结局指标
主要结局
Time to Hemostasis
时间窗: 1 day
Time interval in minutes beginning with sheath removal and ending with removal of hemostatic device and/or observed hemostasis
次要结局
- Number of Participants With Evidence of Hand/Digit Ischemia(30 days)
- Number of Participants With Minor Access Site Bleeding(At time of follow up office visit, if done within 45 days post procedure)
- Number of Participants With Hematoma Formation(1 day)
- Number of Participants With Bruising, Swelling, or Redness(30 days)
- Number of Participants With Level of Post Procedure Healing(At time of follow up office visit, if done within 45 days post procedure)
- Number of Participants Who Had a Readmission(30 days)
- Number of Participants Who Completed Patient Satisfaction Assessment(At time of follow up office visit, if done within 45 days post procedure)
- Number of Participants With Major Access Site Bleeding(Post procedure to prior to discharge, on average same day discharge or up to 1-2 days)
- Visual Analogue Scale (VAS)(At time of follow up office visit, if done within 45 days post procedure)