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临床试验/NCT04975425
NCT04975425已完成不适用

Effects of Guiding Catheter on Fractional Flow Reserve and Non-Hyperemic Pressure Ratios for the Assessment of Coronary Artery Stenoses - Disengage @Rest

Federico II University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年7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
200
试验地点
1
主要终点
Differences between FFR before and after guiding catheter disengagement

研究概览

简要总结

The DISENGAGE@rest study is a prospective registry carried out at Federico II University of Naples with the aim to evaluate the influence of the guiding catheter engagement within the coronary ostium on both FFR and non-hyperaemic pressure ratios values (such as Pd/Pa and the Resting Full-cycle Ratio -RFR), as well as the corresponding clinical impact on decision-making strategies. Consecutive patients with at least one intermediate stenosis (40%-90% by visual estimation) in any of the 3 main coronary arteries will be included.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • Age > 18 years;
  • Patients provides informed consent;
  • Documented coronary artery disease:
  • chronic coronary syndromes
  • acute coronary syndromes presenting with at least one stenosis with indication for invasive functional assessment.

排除标准

  • Patients unable to provide informed consent;
  • Pregnant women;
  • Any contraindication to perform angiographic study or functional evaluation with pressure wire;
  • Patients with aorto-ostial stenosis
  • Target vessel diameter < 2mm

结局指标

主要结局

Differences between FFR before and after guiding catheter disengagement

时间窗: 10 minutes

Evaluate the influence of the guiding catheter engagement within the coronary ostium on FFR values.

1. Differences between NHPR before and after guiding catheter disengagement

时间窗: 10 minutes

Evaluate the influence of the guiding catheter engagement within the coronary ostium on NHPR values

次要结局

未报告次要终点

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giovanni Esposito

Full Professor of Cardiology

Federico II University

研究点 (1)

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