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Completed

NCT Number: NCT03082989

Evolving Routine Standards in Intracoronary Physiology

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Ferrara

Cona, Ferrara, 44124, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

  • written consent denied

Treatment and study plan

fractional flow reserve performed

Device

assessing fractional flow reserve to drive revascularization

fractional flow reserve not performed

Other

description of the main reasons leading the operator to not use fractional flow reserve to drive the coronary revascularization

Primary outcomes

  1. agreement with current guidelines

    Time frame: intra-procedure

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

Secondary outcomes

  1. reasons leading to FFR disuse

    Time frame: intra-procedure

    description of the main reasons leading operator to prefer not assessment of coronary

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Collaborators

  • Società Italiana di Cardiologia Invasiva

Registry information

Official study title

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

Acronym: ERIS

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 17, 2017
Registry last updated
May 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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