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Fast Assessment of STenosis Severity- FASTII Study

NCT ID: NCT03791320

Last Updated: 2020-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

330 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-15

Study Completion Date

2019-11-01

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Keywords

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Fractional Flow Reserve Coronary Physiology 3D-QCA Percutaneous coronary intervention

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Vessel Fractional Flow Reserve

FFR measurement based on coronary angiography

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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3D-QCA based FFR

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tokyo Medical University

OTHER

Sponsor Role collaborator

Centro Cardiologico Monzino

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role collaborator

University Hospital Carl Gustav Carus

OTHER

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Joost Daemen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joost Daemen, MD;PhD.

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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Columbia University Medical Center

New York, New York, United States

Site Status

CHU

Lille, , France

Site Status

Herzzentrum Dresden

Dresden, , Germany

Site Status

Centro Cardiologico Monzino

Milan, , Italy

Site Status

Tokyo Medical University

Tokyo, , Japan

Site Status

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status

Countries

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United States France Germany Italy Japan Netherlands

References

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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.

Reference Type DERIVED
PMID: 34647890 (View on PubMed)

Other Identifiers

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FASTII Study: June 26, 2018

Identifier Type: -

Identifier Source: org_study_id