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临床试验/NCT02373826
NCT02373826Unknown不适用

Novel Method for Real Time Co-Registration of IVUS and Coronary Angiography

Hillel Yaffe Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Accuracy of Co-Registration of IVUS and Coronary Angiography

研究概览

简要总结

During coronary angiography, the lumen of the arteries is imaged but intravascular ultrasound (IVUS) is necessary to determine the plaque extension and its composition, lesion length and luminal reference diameter. We aimed to investigate the accuracy, feasibility, safety and value of a novel method for co-registration of IVUS and coronary angiographic images.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing routine coronary angioplasty

排除标准

  • Cardiogenic shock
  • Acute myocardial infarction

结局指标

主要结局

Accuracy of Co-Registration of IVUS and Coronary Angiography

时间窗: One month

For determination of the accuracy of the co-registration feature, and the accuracy and precision of the length measurements, a flexible phantom was used in order to simulate an artery and enable simulation of the cardiac motion. The sample size for testing the co-registration algorithm was 108 samples (each sample was defined as a landmark). The resultant mean of the absolute distance accuracy was 0.995 mm with a standard deviation of 0.809 mm. The statistical validation in phantoms, resulted in an accuracy of 1.12 mm, meeting the original specification.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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