Long-term Outcome of Deferred Lesion Based on FFR
HALE-BOPP
The Prospective Assessment of Long-term Outcome of Deferred Coronary Lesions Based on FFR Evaluation
1 other identifier
observational
1,305
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2017
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 8, 2017
CompletedFirst Posted
Study publicly available on registry
March 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2022
CompletedMarch 27, 2025
September 1, 2022
4.1 years
March 8, 2017
March 24, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
target vessel failure
cumulative occurrence of cardiac death, target vessel myocardial infarction and ischemia-driven target vessel revascularization. The vessel is defined target if it was that where fractional flow reserve is performed.
1 year
Secondary Outcomes (2)
target vessel failure
3 years
target vessel failure
5 years
Study Arms (1)
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
Interventions
assessment with FFR in at least one coronary lesion
Eligibility Criteria
all patients with established or suspected ischemic heart disease referred for coronary artery angiography in which at least 1 lesion is evaluated by FFR.
You may qualify if:
- written consent
- age \>18 years
- FFR assessment in at least one coronary lesion
You may not qualify if:
- life expectancy \<1 year because of known noncardiovascular comorbidity
- unwillingness to provide written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Clinica Montevergine SPA
Mercogliano, Avellino, Italy
Istituto Clinico Sant'Anna
Brescia, Brescia, Italy
Ospedale Valduce
Como, Como, Italy
University Hospital of Ferrara
Cona, Ferrara, 44124, 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
Related Publications (1)
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.
PMID: 39077421DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 8, 2017
First Posted
March 14, 2017
Study Start
March 1, 2017
Primary Completion
March 30, 2021
Study Completion
August 3, 2022
Last Updated
March 27, 2025
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share