跳至主要内容
临床试验/NCT03082989
NCT03082989已完成不适用

Prospective Study Evaluating the Routine Standard Use of Fractional Flow Reserve and Disagreement With Guideline Recommendations: a Nationwide Study

University Hospital of Ferrara1 个研究点 分布在 1 个国家目标入组 1,858 人开始时间: 2017年3月13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
1,858
试验地点
1
主要终点
agreement with current guidelines

研究概览

简要总结

Italy is the European country with the minor penetration of FFR as compared to the number of percutaneous coronary intervention.

Accordingly, the Società Italiana di Cardiologia Invasiva (SICI-GISE) conceived and promoted a prospective nationwide study to describe the patterns of the use of FFR in an unselected real-world population and to to assess the reasons, on clinical decision making, driving operators in the use or not of the FFR.

详细描述

Fractional flow reserve (FFR) has been validated as a reliable surrogate for inducible ischemia, supporting its use during invasive procedures for functional assessment of coronary lesions. Landmark randomized trials have demonstrated that deferral of nonsignificant lesions based on FFR is not only safe, but also that FFR-guided revascularization is associated with a better clinical outcome up to 2 years, when compared with standard angiography.

In spite of the overwhelming evidence of its potential clinical and economic benefits and strong guideline recommendation, the adoption of FFR in the real-world is perceived to vary significantly. Reasons for this disparity are several, but most operators still do rely the most on angiographic eye-balling to decide on the functional significance of coronary lesions and the need for revascularization.

Italy is the European country with the minor penetration of FFR as compared to the number of percutaneous coronary intervention.

Accordingly, the Società Italiana di Cardiologia Invasiva (SICI-GISE) conceived and promoted a prospective nationwide study to describe the patterns of the use of FFR in an unselected real-world population and to to assess the reasons, on clinical decision making, driving operators in the use or not of the FFR.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • FRACTIONAL FLOW RESERVE PERFORMED GROUP
  • age >18 years
  • written consent
  • assessment with FFR of at least one coronary lesion
  • FRACTIONAL FLOW RESERVE NOT PERFORMED GROUP
  • age >18 years
  • written consent
  • absence of assessment with FFR of at least one coronary lesion
  • + at least one of the following criteria
  • stable coronary artery disease, absence of non-invasive stress test, evidence of coronary lesions between 50%-90% (visual estimation or quantitative coronary analysis)
  • stable coronary artery disease, presence of non-invasive stress test, evidence of coronary lesions between 50%-70% (visual estimation or quantitative coronary analysis)
  • acute coronary syndrome, culprit lesion not identifiable or coronary lesions different from the culprit between 50%-70% (visual estimation or quantitative coronary analysis)

排除标准

  • written consent denied

结局指标

主要结局

agreement with current guidelines

时间窗: intra-procedure

percentage of patients receiving a FFR assessment in agreement with current guidelines

次要结局

  • reasons leading to FFR disuse(intra-procedure)

研究者

发起方
University Hospital of Ferrara
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gianluca Campo

Associate Professor

University Hospital of Ferrara

研究点 (1)

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