Evolving Routine Standards in Intracoronary Physiology

Myocardial Ischemia Clinical Trial

— ERIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03082989
• Other study ID #: 110109
• Status: Completed
• Start date: March 13, 2017
• Est. completion date: October 20, 2017

Study information

• Verified date: May 2018
• Source: University Hospital of Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1858
• Est. completion date: October 20, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

1. stable coronary artery disease, absence of non-invasive stress test, evidence of coronary lesions between 50%-90% (visual estimation or quantitative coronary analysis)

2. stable coronary artery disease, presence of non-invasive stress test, evidence of coronary lesions between 50%-70% (visual estimation or quantitative coronary analysis)

3. 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Intervention

Device:
• fractional flow reserve performed
assessing fractional flow reserve to drive revascularization

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

Locations

Country	Name	City	State
Italy	University Hospital of Ferrara	Cona	Ferrara

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of Ferrara	Società Italiana di Cardiologia Invasiva

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	agreement with current guidelines	percentage of patients receiving a FFR assessment in agreement with current guidelines	intra-procedure
Secondary	reasons leading to FFR disuse	description of the main reasons leading operator to prefer not assessment of coronary	intra-procedure