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临床试验/NCT00842179
NCT00842179已完成不适用

Femoral Access Site Groin Complication Rates After 2517 Groin Punctures Undergoing Vascular Closure by Either Manual Compression or the Perclose Vascular Closure Device

Clinyx, LLC1 个研究点 分布在 1 个国家目标入组 2,517 人开始时间: 2008年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,517
试验地点
1
主要终点
major vascular complications

研究概览

简要总结

The objective of this study is to compare groin complication rates in low and high risk patients post percutaneous coronary intervention (PCI) closed by either a 6 French Perclose vascular closure device (VCD) or manual compression.

详细描述

It is commonly accepted that that there exists a learning curve in performing successful groin closure with Vascular Closure Devices (VCD). Manual compression continues to be 'standard of care' at most institutions for closure of 5 - 8 French femoral arteriotomies, as previous studies evaluating the safety and efficacy of vascular closure devices have failed to show a statistically significant decrease in groin complication rates when compared to manual compression. Importantly, no studies to date have been performed to specifically assess the potential decrease in vascular complication rates by highly experienced VCD operators, when their safety results are compared to manual compression. This retrospective, multi-center study will demonstrate a lower vascular complication rate in PCI patients post deployment of a 6 Fr Perclose VCD by a single, experienced operator, when compared to manual compression in two comparable, high volume, hospital cardiac catheterization laboratories.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Patients who received vascular closure with the Perclose device post PCI at Baptist Miami Hospital
  • Patients who received vascular closure by manual compression at Tampa General Hospital

排除标准

  • Patients less than 18 years old

结局指标

主要结局

major vascular complications

时间窗: 0-30 days (during Index hospitalization)

次要结局

  • Minor vascular complications(0-30 days (during index hospitalization))

研究者

发起方
Clinyx, LLC
申办方类型
Other

研究点 (1)

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