Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03079739 |
| Other study ID # |
161082 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2017 |
| Est. completion date |
August 3, 2022 |
Study information
| Verified date |
September 2022 |
| Source |
University Hospital of Ferrara |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
