Clinical trial NCT03791320: Fast Assessment of STenosis Severity- FASTII Study
Official title: Multicenter Validation of 3D-QCA Based FFR vs. Pressure Wire Based FFR: The FAST-II Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Fractional Flow Reserve
Coronary Physiology
3D-QCA
Percutaneous coronary intervention
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Tokyo Medical University
name: Centro Cardiologico Monzino
name: Columbia University
name: University Hospital Carl Gustav Carus
name: University Hospital, Lille
First posted: 2019-01-02
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients ≥ 18 years presenting with stable or unstable angina or non-ST elevation acute coronary syndrome.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic accuracy of vFFR to identify FFR (≤0.8 or >0.8) calculated by corelab
timeFrame: 1 year
Secondary outcomes:
measure: Diagnostic accuracy of vFFR to identify FFR (≤0.8 or >0.8) calculated by site/operator
timeFrame: 1 year
measure: Interobserver variability
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Lille
country: France
facility: CHU
city: Dresden
country: Germany
facility: Herzzentrum Dresden
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
city: Tokyo
country: Japan
facility: Tokyo Medical University
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
affiliation: Erasmus Medical Center
name: Joost Daemen, MD;PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Masdjedi K, Tanaka N, Van Belle E, Porouchani S, Linke A, Woitek FJ, Bartorelli AL, Ali ZA, den Dekker WK, Wilschut J, Diletti R, Zijlstra F, Boersma E, Van Mieghem NM, Spitzer E, Daemen J. Vessel fractional flow reserve (vFFR) for the assessment of stenosis severity: the FAST II study. EuroIntervention. 2022 Apr 22;17(18):1498-1505. doi: 10.4244/EIJ-D-21-00471.