Clinical Study of the St. Jude Medical Angio-Seal VIP Vascular Closure Device Following Diagnostic and/or Interventional Endovascular Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Device deployment characteristics and performance
研究概览
简要总结
The purpose of this clinical study is to assess device deployment characteristics and performance, as well as adverse events (vascular complications) of the SJM Angio-Seal VIP 6 French device utilizing the SJM collagen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 is undergoing a diagnostic and/or interventional endovascular procedure via a retrograde femoral arterial access.
- •Patient is of legal age.
- •Patient has given written informed consent for participation prior to the procedure.
- •Patient is willing to undergo all study procedures and adhere to data collection and follow-up requirements.
排除标准
- •Patient is unable to provide written informed consent.
- •Patient has an inability or is unwilling to adhere to data collection and follow-up requirements.
- •Patients who are pregnant or lactating.
- •Patient may not participate in another clinical trial which has the potential to impact hemostasis (pharmaceutical/ device/ homeopathic).
结局指标
主要结局
Device deployment characteristics and performance
时间窗: At procedure
Device Deployment Success and rationale for non-deployment, procedural circumstances present during deployment such as type of procedure and procedure duration, Time to hemostasis, and assessment of vascular complications prior to leaving the cath lab. Data will be summarized using descriptive statistics in addition to listings or summary data tables being provided.
Adverse events (vascular complications)
时间窗: Ongoing
Adverse events (vascular complications) out to 30 days post-procedure on patients who have undegone a diagnostic and/or interventional procedure.
次要结局
- Time to hemostasis(The time elapsed from device deployment (cutting of the suture) to complete cessation of arterial bleeding, stratified as hemostasis in less than 1 minute, 1-5 minutes, or greater than 5 minutes.)
- Rate of minor vascular complications(Ongoing)