跳至主要内容
临床试验/NCT03074721
NCT03074721Unknown不适用

PCI Suite: Road Map Fusion Imaging in Coronary Diagnostics and Therapy

Heinrich-Heine University, Duesseldorf2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2017年4月24日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
130
试验地点
2
主要终点
Amount of contrast medium

研究概览

简要总结

The PCI Suite is developed by Philips Medical Systems, a Philips Healthcare company. The proposed PCI Suite is a new software package which can be used during coronary interventions. The software package includes two sub-packages, known as StentBoost and Cardiac Roadmapping.

The patient will undergo standard of care medical treatment for his or her cardiac condition. During the procedure, the physician may make angiograms for diagnosis and as reference for device navigation as part of the standard care. These angiograms will be automatically processed in PCI Suite and displayed on fluoroscopy for navigation support. In case a balloon catheter is inserted into the coronary arteries, the physician may take cine images as part of the standard care. These images can be automatically enhanced in PCI Suite. The primary objective of this prospective, mono-center, randomized clinical trial is to evaluate the amount of contrast medium used during percutaneous coronary intervention.

研究设计

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

  • hemodynamically relevant type A or B lesion

排除标准

  • hemodynamically relevant type C lesion
  • NSTEMI/STEMI
  • declined to participate

结局指标

主要结局

Amount of contrast medium

时间窗: Baseline

Determination during PCI

次要结局

  • Major adverse cardiac and cerebrovascular events(Baseline, after 6 months, after 12 months)
  • Procedural success(Baseline)
  • Procedure duration(Baseline)
  • area dosage product(Baseline)

研究者

发起方
Heinrich-Heine University, Duesseldorf
申办方类型
Other
责任方
Sponsor

研究点 (2)

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