Ignite Creation Date:
2024-05-06 @ 9:47 AM
Last Modification Date:
2024-10-26 @ 12:20 PM
Study NCT ID:
NCT03079739
Status:
COMPLETED
Last Update Posted:
2022-09-10
First Post:
2017-03-08
Brief Title:
Long-term Outcome of Deferred Lesion Based on FFR
Sponsor:
University Hospital of Ferrara
Organization:
University Hospital of Ferrara
Study Overview
Official Title:
The Prospective Assessment of Long-term Outcome of Deferred Coronary Lesions Based on FFR Evaluation
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HALE-BOPP
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 patients 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
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None