ACTRN12610000831088已完成未知
Femoral Artery closure using the Cardiva Vascular Closure System (VCS) to reduce time to hemostasis and reduce time to ambulation
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Clinically indicated for an diagnostic or interventional endovascular procedure anticipated to employ common femoral artery access using a modified Seldinger technique and a 6F or 7F introducer sheath
排除标准
- •Key PRE-OPERATIVE EXCLUSION CRITERIA
- •1.Septicemia or a cutaneous/subcutaneous groin infection
- •2.Ipsilateral femoral arteriotomy within the previous 30 days
- •3.Planned arterial access at the same site within the next 90 days
- •4.Extreme morbid obesity (Body mass index (BMI) greater than 45 kg/m2) or underweight (BMI less than 22 kg/m2)
- •5.Femoral artery diameter less than 6 mm
- •6.Difficulty achieving arterial access and/or inserting the introducer sheath at the onset of the procedure (e.g., multiple stick attempts)
- •7.Fluoroscopically visible calcium, atherosclerotic disease, or stent within 1 cm of the puncture site
研究者
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