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临床试验/NCT04593667
NCT04593667已完成不适用

Utilizing a Novel Agent in a Randomized Study of Accelerated Radial Arterial Hemostasis Under Reduced Compression Following Percutaneous Transradial Coronary Angiography/Intervention

Medcura Inc.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年11月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Medcura Inc.
入组人数
60
试验地点
1
主要终点
Compressive Force

研究概览

简要总结

Clinical randomized study to evaluate the effect of using a hydrophobically modified polysaccharide (hm-P) bandage

详细描述

The study will evaluate the clinical performance (e.g. hemostatic and patient outcomes) of this hm-P bandage by using an earlier time for removal of the bandage (e.g. 60 minutes) than the current standard of care (e.g. 90-180 minutes) while also reducing the inflated pressure of the band, and hence the compressive force put on the wrist of the patient, in increments of the % of inflation as per current protocol, with N=20 @ 100%, N=20 @ 75%, & N=20 @ 50%. This study will be completed while maintaining vascular integrity and patency through visualization in patients undergoing angiographic procedures via anticoagulated, percutaneous radial arterial cannulation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • Current patients who are undergoing diagnostic and interventional coronary/vascular angiography via a transradial approach with or without planned coronary or peripheral intervention.

排除标准

  • 未提供

结局指标

主要结局

Compressive Force

时间窗: 60 minutes

Change in the compressive force onto the access site

Time to hemostasis

时间窗: 60 minutes

Significant change in time to hemostasis

次要结局

  • Radial Artery(immediately after hemostasis)

研究者

发起方
Medcura Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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