Long-term Outcome of Deferred Lesion Based on FFR (HALE-BOPP)
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|ClinicalTrials.gov Identifier: NCT03079739|
Recruitment Status : Active, not recruiting
First Posted : March 14, 2017
Last Update Posted : October 15, 2019
|Condition or disease||Intervention/treatment|
|Myocardial Ischemia||Diagnostic Test: fractional flow reserve|
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.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||1305 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||The Prospective Assessment of Long-term Outcome of Deferred Coronary Lesions Based on FFR Evaluation|
|Actual Study Start Date :||March 1, 2017|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||August 31, 2024|
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
Diagnostic Test: fractional flow reserve
assessment with FFR in at least one coronary lesion
- target vessel failure [ Time Frame: 1 year ]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.
- target vessel failure [ Time Frame: 3 years ]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.
- target vessel failure [ Time Frame: 5 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079739
|Clinica Montevergine SPA|
|Mercogliano, Avellino, Italy|
|University Hospital of Ferrara|
|Cona, Ferrara, Italy, 44124|
|Ospedale San Filippo e Nicola|
|Avezzano, L'Aquila, Italy|
|Clinica San Carlo|
|Paderno Dugnano, Milano, Italy|
|Istituto Clinico Sant'Anna|
|Istituto Auxologico Italiano|
|AOU di Sassari|