Fast Assessment of STenosis Severity- FASTII Study

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT03791320
• Lead Sponsor: Erasmus Medical Center

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.

Study Timeline

• Study Start: 2018-10-15
• Study First Submitted: 2018-12-20
• Study First Submitted QC: 2018-12-29
• Study First Posted: 2019-01-02
• Primary Completion: 2019-09-01
• Study Completion: 2019-11-01
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-23
• Last Update Posted: 2020-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (6)

Tokyo Medical University; 🇯🇵 Tokyo, Japan

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

CHU; 🇫🇷 Lille, France

Centro Cardiologico Monzino; 🇮🇹 Milan, Italy

Herzzentrum Dresden; 🇩🇪 Dresden, Germany

Columbia University Medical Center; 🇺🇸 New York, New York, United States