Long-term Outcome of Deferred Lesion Based on FFR

NCT ID: NCT03079739

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1305 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2022-08-03

Brief Summary

Treatment of ischemic myocardium with percutaneous coronary intervention (PCI) in addition to optimal medical therapy reduces major adverse cardiac events. However, less than half of patients have a noninvasive ischemic evaluation before revascularization. Fractional flow reserve (FFR) can determine the hemodynamic significance of a coronary lesion by measuring the distal mean coronary and aortic pressures during maximal hyperemia. Previous studies conducted principally in stable coronary artery disease (CAD) patients have demonstrated that FFR-guided revascularization improves clinical outcomes, quality of life, and cost-efficiency. However, the reliability and safety of FFR assessment in different setting than stable CAD is unclear. In addition, the majority of studies are performed with the only one device. No data are available from other clinically used devices. The HALE BOPP registry is an investigator-initiated observational study, designed to prospectively include all patients referred for coronary angiography in which at least 1 lesion was evaluated by FFR.

Detailed Description

Treatment of ischemic myocardium with percutaneous coronary intervention (PCI) in addition to optimal medical therapy reduces major adverse cardiac events. However, less than half of patients have a noninvasive ischemic evaluation before revascularization. Fractional flow reserve (FFR) can determine the hemodynamic significance of a coronary lesion by measuring the distal mean coronary and aortic pressures during maximal hyperemia. Previous studies conducted principally in stable coronary artery disease (CAD) patients have demonstrated that FFR-guided revascularization improves clinical outcomes, quality of life, and cost-efficiency. However, the reliability and safety of FFR assessment in different setting than stable CAD is unclear. In addition, the majority of studies are performed with the only one device. No data are available from other clinically used devices.

The HALE BOPP registry is an investigator-initiated observational study, designed to prospectively include all patients referred for coronary angiography in which at least 1 lesion was evaluated by FFR.

All centers capable of performing FFR were invited to participate and there were no predefined exclusion criteria, other than the patient's unwillingness to provide written informed consent.

The decision to perform FFR was left to the operator in each case. The study primary purpose was to evaluate, in the routine daily practice, the long-term clinical outcome of coronary lesions where the treatment was deferred based on FFR result.

An independent corelab will review all angiograms to perform quantitative coronary analysis, calculation of syntax score, residual syntax score, functional syntax score and, in ACS patients, discrimination between culprit and non culprit lesions An indipendent committee will assess and adjudicate all adverse events.

Conditions

Myocardial Ischemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

fractional flow reserve group

consecutive patients undergoing coronary artery angiography for established or suspected ischemic heart disease and receiving in at least one lesion FFR assessment

fractional flow reserve

Intervention Type: DIAGNOSTIC_TEST

assessment with FFR in at least one coronary lesion

Interventions

fractional flow reserve

assessment with FFR in at least one coronary lesion

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• written consent
• age >18 years
• FFR assessment in at least one coronary lesion

Exclusion Criteria

• life expectancy <1 year because of known noncardiovascular comorbidity
• unwillingness to provide written informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Gianluca Campo

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinica Montevergine SPA

Mercogliano, Avellino, Italy

Istituto Clinico Sant'Anna

Brescia, Brescia, Italy

Ospedale Valduce

Como, Como, Italy

University Hospital of Ferrara

Cona, Ferrara, Italy

Clinica Sant'Ambrogio

Milan, Milano, Italy

Istituto Auxologico Italiano

Milan, Milano, Italy

Clinica San Carlo

Paderno Dugnano, Milano, Italy

AOU di Sassari

Sassari, Sassari, Italy

Countries

Italy

References

Tebaldi M, Gallo F, Scoccia A, Durante A, Tedeschi D, Verdoliva S, Cortese B, Bilotta F, Watkins S, Ielasi A, Valentini G, Pavasini R, Serenelli M, D'Aniello E, Arena M, Pompei G, Scala A, Scollo E, Gibiino F, Caglioni S, Mele D, Marrone A, Biscaglia S, Barbato E, Campo G. Clinical Outcome of FFR-Guided Revascularization Strategy of Coronary Lesions: The HALE-BOPP Study. Rev Cardiovasc Med. 2023 Feb 14;24(2):62. doi: 10.31083/j.rcm2402062. eCollection 2023 Feb.

Reference Type: DERIVED

PMID: 39077421 (View on PubMed)

Other Identifiers

161082

Identifier Type: -

Identifier Source: org_study_id