NCT03082989

Evolving Routine Standards in Intracoronary Physiology

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,858 (actual)
• Sponsor: University Hospital of Ferrara · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Ischemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-03-13
• Primary completion: 2017-09-30
• Completion: 2017-10-20
• First posted: 2017-03-17
• Last updated: 2018-05-04

Locations

1 site across 1 country: Italy