临床试验/ACTRN12611001247965

ACTRN12611001247965招募中未知

Femoral Artery closure using the Cardiva VASCADE 5F Vascular Closure System (VCS) to reduce time to hemostasis and reduce time to ambulation and hospital discharge in patients who have undergone diagnostic or interventional endovascular catheterization procedures utilizing 5 French procedural sheaths

Cardiva Medical, Inc.0 个研究点目标入组 30 人开始时间: 2011年12月6日最近更新: 2020年1月13日

适应症

试验速览

阶段: 未知
状态: 招募中
发起方: Cardiva Medical, Inc.
入组人数: 30

研究概览研究设计入排标准研究者记录与标识符相似试验

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 80 Years（—）
性别: All

入选标准

•Clinically indicated for an elective, non-emergent diagnostic or interventional endovascular procedure via the common femoral artery using a 5 Fr introducer sheath

排除标准

•Key Pre-Operative Exclusion Criteria
•1. Active systemic or a cutaneous infection
•2. Pre-existing immunodeficiency disorder and/or chronic use of systemic steroids
•3. Ipsilateral femoral arteriotomy within the previous 30 days
•4. Planned endovascular procedure within the next 30 days
•5. Unilateral or bilateral lower extremity amputation(s)
•6. Extreme morbid obesity [Body Max Index (BMI) greater than 45 kg/m2] or underweight (BMI less than 22 kg/m2)
•7. Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure (e.g., multiple stick attempts, backwall stick”, etc.)
•8. Fluoroscopically visible calcium, atherosclerotic disease, or stent within 1 cm of the puncture site

研究者

发起方

Cardiva Medical, Inc.

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