Fast Assessment of STenosis Severity- FASTII Study

Erasmus University

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Diagnostic Test: Vessel Fractional Flow Reserve

Study type: Observational

Funder types: Other

Identifiers

NCT03791320

FASTII Study: June 26, 2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 330 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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