Fast Assessment of STenosis Severity- FASTII Study (FASTII)

Multicenter Validation of 3D-QCA Based FFR vs. Pressure Wire Based FFR: The FAST-II Study

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: Vessel Fractional Flow Reserve

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 Type: Observational
• Enrollment (Actual): 330

Contacts and Locations

Study Locations

• France
  • Lille, France
    • CHU
• Germany
  • Dresden, Germany
    • Herzzentrum Dresden
• Italy
  • Milan, Italy
    • Centro Cardiologico Monzino
• Japan
  • Tokyo, Japan
    • Tokyo Medical University
• Netherlands
  • Rotterdam, Netherlands
    • Erasmus Medical Center
• United States
  • New York
    • New York, New York, United States, 10027
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients ≥ 18 years presenting with stable or unstable angina or non-ST elevation acute coronary syndrome.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Columbia University; University Hospital, Lille; Centro Cardiologico Monzino; University Hospital Carl Gustav Carus; Tokyo Medical University
• Investigators: Principal Investigator: Joost Daemen, MD;PhD., Erasmus MC

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: December 29, 2018
• First Posted (Actual): January 2, 2019

Study Record Updates

• Last Update Posted (Actual): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 23, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Percutaneous coronary intervention; Fractional Flow Reserve; Coronary Physiology; 3D-QCA
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: FASTII Study: June 26, 2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data are needed for the final analysis which will be done by Erasmus MC.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No