Coronary Artery Disease
Conditions
Keywords
Fractional Flow Reserve, Coronary Physiology, 3D-QCA, Percutaneous coronary intervention
Brief summary
The Multicenter FAST (Fast Assessment of STenosis severity) study is a prospective observational multicenter study designed to evaluate the diagnostic accuracy of offline 3D-QCA based FFR, using CAAS Workstation (Pie Medical Imaging, Maastricht, the Netherlands) in identifying hemodynamically significant coronary artery disease with pressure wire-based FFR (≤0.80) as the reference standard.
Detailed description
The Multicenter FAST study is a prospective observational multicenter international study in which offline computation of vFFR is compared to conventional invasive, wire based FFR measurements. Pressure wire based FFR will be performed in patients with at least one intermediate coronary lesion at the discretion of the operator (typically defined as a coronary artery lesion with a diameter stenosis of 30-70% by visual assessment). A total of 3 two-dimensional angiography images, will be recorded and exported to the CAAS workstation 8.0 (Pie Medical Imaging, Maastricht, the Netherlands): two orthogonal views to create a 3D reconstruction of the coronary arteries and one view to ascertain the position of the FFR pressure wire. vFFR will be calculated automatically, by using the invasively measured aortic root pressure. vFFR measurements will be performed online by the different centers. In addition, all angiographic imaging data will be sent to an independent core laboratory (Cardialysis, Rotterdam, The Netherlands) for offline analysis.
Interventions
DIAGNOSTIC_TESTVessel Fractional Flow Reserve
FFR measurement based on coronary angiography
Sponsors
Tokyo Medical University
Centro Cardiologico Monzino
Columbia University
University Hospital Carl Gustav Carus
University Hospital, Lille
Erasmus Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients ≥ 18 years * indication procedure: stable, unstable angina or non-ST elevation acute coronary syndrome * Diagnostic coronary angiography or PCI with an indication to perform re-PCI FFR assessment of at least one coronary artery lesion.
Exclusion criteria
* ST-elevation myocardial infarction (STEMI) * Cardiogenic shock * Severe hemodynamic instability * Adenosine intolerance * Lesions containing thrombus, left main lesions, grafts, arteries with collaterals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of vFFR to identify FFR (≤0.8 or >0.8) calculated by corelab | 1 year | The diagnostic accuracy of offline vFFR assessed by a blinded independent core laboratory to identify hemodynamically-significant coronary stenosis with FFR (≤0.8 or \>0.8) as the reference standard. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of vFFR to identify FFR (≤0.8 or >0.8) calculated by site/operator | 1 year | The diagnostic accuracy of operator or cathlab technician calculated online vFFR to identify hemodynamically-significant coronary stenosis with FFR (≤0.8 or \>0.8) as the reference standard. |
| Interobserver variability | 1 year | 3D-QCA based FFR (vFFR) will be calculated twice: by the operator/technician of different centers AND by an independent corelab (Cardoalysis). Correlation and agreement between these two measurements will be assessed in order to investigate the Inter-observer variability. |
Countries
France, Germany, Italy, Japan, Netherlands, United States
Outcome results
None listed