Coronary Artery Disease Clinical Trial
— FASTIIOfficial title:
Multicenter Validation of 3D-QCA Based FFR vs. Pressure Wire Based FFR: The FAST-II Study
Verified date | December 2020 |
Source | Erasmus Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Erasmus Medical Center | Centro Cardiologico Monzino, Columbia University, Tokyo Medical University, University Hospital Carl Gustav Carus, University Hospital, Lille |
United States, France, Germany, Italy, Japan, Netherlands,
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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