Fast Assessment of STenosis Severity- FASTII Study

NCT03791320 | Completed

• 1 other identifier: FASTII Study: June 26, 2018
• Study Type: observational
• Target: 330
• Locations: 6 countries
• Sites: 6

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.

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Diagnostic accuracy of vFFR to identify FFR (≤0.8 or >0.8) calculated by site/operator

  1 year

• Interobserver variability

  1 year

Interventions

Vessel Fractional Flow Reserve DIAGNOSTIC_TEST

FFR measurement based on coronary angiography

Also known as: 3D-QCA based FFR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• ST-elevation myocardial infarction (STEMI)
• Cardiogenic shock
• Severe hemodynamic instability
• Adenosine intolerance
• Lesions containing thrombus, left main lesions, grafts, arteries with collaterals

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Tokyo Medical University: collaborator
• Centro Cardiologico Monzino: collaborator
• Columbia University: collaborator
• University Hospital Carl Gustav Carus: collaborator
• University Hospital, Lille: collaborator

Study Sites (6)

Columbia University Medical Center

New York, New York, 10027, United States

Location

CHU

Lille, France

Location

Herzzentrum Dresden

Dresden, Germany

Location

Centro Cardiologico Monzino

Milan, Italy

Location

Tokyo Medical University

Tokyo, Japan

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 34647890 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Joost Daemen, MD;PhD.

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: January 2, 2019
• Study Start: October 15, 2018
• Primary Completion: September 1, 2019
• Study Completion: November 1, 2019
• Last Updated: December 24, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); JP (1); DE (1); IT (1); NL (1); FR (1)