临床试验/NCT04831008

NCT04831008已完成不适用

Comparison of Figure-Of-Eight Suture and Perclose ProGlide Suture-Mediated Closure System in Achieving Hemostasis After a Large Bore Venous Access.

Delray Medical Center2 个研究点分布在 1 个国家目标入组 50 人开始时间: 2020年8月6日最近更新: 2023年1月11日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Delray Medical Center
入组人数: 50
试验地点: 2
主要终点: Hemostasis Time

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study proposes to compare specialized closure devices to achieve hemostasis with the Figure-of-eight suture technique.

详细描述

Procedures where patients requiring large bore venous access will be randomized 1:1 to either the Figure-of-eight suture technique or the Perclose Device to achieve hemostasis.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Other
盲法: Single (Participant)

入排标准

年龄范围: 18 Years 至 90 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•All patients who successfully undergo venous large bore access sheath placement for structural heart procedures.

排除标准

•Patients who do not consent
•Minors or those unable to consent

结局指标

主要结局

Hemostasis Time

时间窗: Immediate

To assess if an additional device use to achieve hemostasis can be avoided after a large bore venous access

Procedure Time

时间窗: Immediate

Access Site Complication

时间窗: 1 month

次要结局

未报告次要终点

研究者

发起方

Delray Medical Center

申办方类型

Other

责任方

Principal Investigator

主要研究者

Houman Khalili MD

Principal Investigator

Delray Medical Center

研究点 (2)

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