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临床试验/NCT02154295
NCT02154295已完成不适用

Simultaneous Acquisition of Intravascular Ultrasound and Near Infrared Spectroscopy Data in the Coronary Artery Study

Infraredx2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2014年5月1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
入组人数
16
试验地点
2
主要终点
Clarity of Image and ease of interpretation as measured by physician survey

研究概览

简要总结

The purpose of this study is to investigate and compare the images obtained from coronary imaging catheters used in the treatment of coronary blockages both in a clinical setting with patients and in models.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
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

  • ≥18 years of age
  • Scheduled for a coronary angiogram at the Royal Adelaide Hospital.
  • Women must be non-lactating or not of childbearing potential (1 year post menopausal or surgically sterilized [total hysterectomy, bilateral tubal ligation, bilateral oophorectomy]).
  • Target artery must be >2 mm to accommodate the IVUS catheter.
  • IVUS must be clinically indicated or indeterminate angiographic lesion in the artery (40%-70% angiographic stenosis)

排除标准

  • Cardiogenic shock
  • Contraindications to intracoronary nitroglycerin (hypertrophic obstructive cardiomyopathy; cerebral hemorrhage, head trauma; concomitant sildenafil, tadalafil or vardenafil use)
  • Known coronary artery spasm
  • Significant bleeding risk (i.e. previous hemorrhagic stroke, active peptic ulcer disease)
  • Bleeding diathesis
  • Significant renal impairment (patients will be excluded if their calculated creatinine clearance is < 30 mL/min)

结局指标

主要结局

Clarity of Image and ease of interpretation as measured by physician survey

时间窗: Day 0

次要结局

  • Comparison of diameters and areas using ultrasound imaging from a standard test fixture(model) and test catheters(Day 0)

研究者

发起方
Infraredx
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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