Evolving Routine Standards in Intracoronary Physiology

Completed

• Conditions: Myocardial Ischemia

• Registration Number: NCT03082989
• Lead Sponsor: University Hospital of Ferrara

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-03-13
• Study First Submitted: 2017-03-13
• Study First Submitted QC: 2017-03-13
• Study First Posted: 2017-03-17
• Primary Completion: 2017-09-30
• Study Completion: 2017-10-20
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-01
• Last Update Posted: 2018-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1858

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
agreement with current guidelines	intra-procedure	percentage of patients receiving a FFR assessment in agreement with current guidelines

Secondary Outcome Measures

Name	Time	Method
reasons leading to FFR disuse	intra-procedure	description of the main reasons leading operator to prefer not assessment of coronary

Trial Locations

Locations (1)

University Hospital of Ferrara; 🇮🇹 Cona, Ferrara, Italy