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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03791320
Other study ID # FASTII Study: June 26, 2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 15, 2018
Est. completion date November 1, 2019

Study information

Verified date December 2020
Source Erasmus Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 330
Est. completion date November 1, 2019
Est. primary completion date September 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Vessel Fractional Flow Reserve
FFR measurement based on coronary angiography

Locations

Country Name City State
France CHU Lille
Germany Herzzentrum Dresden Dresden
Italy Centro Cardiologico Monzino Milan
Japan Tokyo Medical University Tokyo
Netherlands Erasmus Medical Center Rotterdam
United States Columbia University Medical Center New York New York

Sponsors (6)

Lead Sponsor Collaborator
Erasmus Medical Center Centro Cardiologico Monzino, Columbia University, Tokyo Medical University, University Hospital Carl Gustav Carus, University Hospital, Lille

Countries where clinical trial is conducted

United States,  France,  Germany,  Italy,  Japan,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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