Fast Assessment of STenosis Severity- FASTII Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multicenter Validation of 3D-QCA Based FFR vs. Pressure Wire Based FFR: The FAST-II Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Diagnostic Test: Vessel Fractional Flow Reserve


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Vessel Fractional Flow Reserve|FFR measurement based on coronary angiography|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of vFFR to identify FFR (≤0.8 or >0.8) calculated by corelab | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of vFFR to identify FFR (≤0.8 or >0.8) calculated by site/operator | 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. | 1 year | 
| Interobserver variability | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fractional Flow Reserve, Coronary Physiology, 3D-QCA, Percutaneous coronary intervention