Angio-based Fractional Flow Reserve to Predict Adverse Events After Stent Implantation (HAWKEYE)
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|ClinicalTrials.gov Identifier: NCT02811796|
Recruitment Status : Active, not recruiting
First Posted : June 23, 2016
Last Update Posted : January 7, 2019
|Condition or disease||Intervention/treatment|
|Prognosis Stents||Other: angio-based FFR estimation|
Fractional flow reserve (FFR) allows to evaluate the functional significance of coronary artery lesions, through the ratio of the mean coronary artery pressure after the stenosis to the mean aortic pressure during maximum hyperaemia. The actual widely accepted cutoff value is 0.80. Below this value, an intermediate coronary lesion is considered significant and its treatment with percutaneous coronary intervention (PCI) is justified.
The measurement FFR after stent implantation has a strong predictive value with respect to death, myocardial infarction, or need for repeat revascularization of the target vessel within 6 months. The higher the FFR, the lower the event rate. FFR cut-off of 0.90 might be a useful indicator in daily practice for optimal physiologic stent implantation. Nevertheless, the use of the FFR in the post stenting , is relatively low, because of costs of the pressure wire and the adverse effects related to the use of adenosine.
A new method (QFR by Medis medical imaging) for evaluation of the functional significance of coronary stenosis is based on computer calculation of the FFR value. This calculation is performed by analysing the coronary angiogram and thus reduces or potentially eliminates the need for measuring FFR by pressure wires. The QFR method combines a 3D reconstructions of the target vessel based on two angiographic projections and the contrast flow velocity to compute the "FFR value". To perform QFR the investigators will acquire two angiographic projections with angle >25 degree that allow the 3D reconstruction of the vessel (see values below).
Projections for left main (LM) and proximal left anterior descending (LAD) or proximal left circumflex (LCX): right anterior oblique (RAO) 20, Caudal 45 and anterior-posterior (AP), Caudal 10
Projections for LAD/diagonal: AP, Cranial 45 and RAO 35, Cranial 20
Projections for LCX/obtuse marginal (OM): left anterior oblique (LAO) 10, Caudal 45 and RAO 25, Caudal 25
Projections for Proximal+Mid right coronary artery (RCA): LAO 45, caudal (CAUD) 0 and AP, CAUD 0
Projections for postero-lateral artery and posterior-descending artery (PLA/PDA): LAO 45, CAUD 0 and LAO 30, CAUD 30
Finally, the investigators will assess the relationship between QFR value and adverse events. We will assess the best QFR value able to discriminate the cumulative occurrence of adverse events. In the study, we will include also ST-segment elevation myocardial infarction patients. This subset of patients will be analysed as independent cohort to obtain preliminary results and will be analysed in a independent study
|Study Type :||Observational|
|Actual Enrollment :||602 participants|
|Official Title:||Prospective Validation of the Angio-based Fractional Flow Reserve (Quantitative Flow Ratio, QFR) System to Discriminate Patients at Risk of Adverse Events After Stent Implantation.|
|Actual Study Start Date :||June 2016|
|Actual Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||July 2022|
angio-based FFR estimation
The investigators will include all patients receiving successful coronary stent implantation. In these patients the investigators will acquire specific angiograms to permit angio-based FFR (QFR) calculation. An independent corelab will estimate the QFR value. This value will be related to prognosis to verify if it is able to discriminate those at higher risk of adverse events.
Other: angio-based FFR estimation
The investigators will acquire specific angiograms to permit angio-based FFR (QFR) calculation. An independent corelab will estimate the QFR value. This value will be related to prognosis to verify if it is able to discriminate those at higher risk of adverse events.
- Device-oriented cardiac events [ Time Frame: 1-year ]cumulative occurrence of cardiac death, target vessel myocardial infarction, target lesion revascularization
- cardiac death [ Time Frame: 1-year ]cumulative occurrence of cardiac death
- all-cause mortality [ Time Frame: 1-year ]cumulative occurrence of all-cause mortality
- any myocardial infarction [ Time Frame: 1-year ]cumulative occurrence of any myocardial infarction
- target vessel revascularization [ Time Frame: 1-year ]cumulative occurrence of target vessel revascularization
- stent thrombosis [ Time Frame: 1-year ]cumulative occurrence of definite, probable and possible stent thrombosis
- hospital admission for all causes [ Time Frame: 1-year ]cumulative occurrence of hospital admission for all causes
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): NCT02811796
|University Hospital of Ferrara|
|Cona, Ferrara, Italy, 44124|
|San Luigi Gonzaga|