Fast Assessment of STenosis Severity- FASTII Study

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.

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