Fractional Flow Reserve or 3D-Quantitative-Coronary-Angiography Based Vessel-FFR Guided Revascularization

Last updated: October 17, 2023
Sponsor: ECRI bv
Overall Status: Active - Recruiting

Phase

N/A

Condition

Atherosclerosis

Heart Disease

Coronary Artery Disease

Treatment

FFR guided revascularization

vFFR guided revascularization

Clinical Study ID

NCT04931771
ECRI-15
  • Ages > 18
  • All Genders

Study Summary

The FAST III is a randomized controlled, open-label, multicenter, international, non-inferiority, strategy trial. A total of 2228 participants will be randomized in a 1:1 fashion to either vFFR- or FFR guided revascularization. Patients will be consented prior to the procedure and then followed up to 12 (+1) months after randomization. The primary endpoint is analyzed at 12 months after randomization. Approximately 35 sites in 7 European countries (Netherlands, Ireland, United Kingdom, Germany, Italy, Spain, and France).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The patient must be ≥18 years of age
  2. Presenting with silent ischemia, stable angina, or non-ST-elevation acute coronarysyndrome (NSTE-ACS)
  3. Coronary artery disease with at least one native artery in which the stenosis severityis questionable (typically 30-80% stenosis)
  4. FFR assessment and vFFR assessment feasible
  5. The patient is willing and able to cooperate with study procedures and follow-up untilstudy completion
  6. Subject is able to confirm understanding of risks, benefits and treatment alternativesand he/she provides informed consent prior to any protocol-related procedure, asapproved by the appropriate Ethics Committee

Exclusion

Exclusion Criteria:

  1. ST-elevation myocardial infarction (STEMI) at presentation
  2. Cardiogenic shock or severe hemodynamic instability at the time of intervention (heartrate<50 beats per minute, systolic blood pressure <90mmHg) or use of left ventricularassist device
  3. Any target vessel with a distal Thrombolysis In Myocardial Infarction (TIMI) flow <3.
  4. Presence of thrombus in intermediate target lesion.
  5. Known untreated severe valvular heart disease
  6. Target lesion is located in or supplied by an arterial or venous bypass graft
  7. History of cardiac allograft transplantation
  8. Aorto-ostial lesions with an estimated diameter stenosis >50%
  9. Severe tortuosity precluding the acquisitions of 2 orthogonal projections of thetarget vessel with minimal overlap or foreshortening.
  10. Absolute contraindications or allergy that cannot be pre-medicated, to iodinatedcontrast or adenosine
  11. Non-cardiac co-morbidities with a life expectancy less than 1 year
  12. Currently participating in another trial that is not yet at its primary endpoint. Thepatient is not allowed to participate in another investigational device or drug studyuntil the trial primary endpoint time point is achieved and may only be enrolled oncein the study
  13. Women of childbearing potential who do not have a negative pregnancy test within 24hours before the procedure
  14. Subject belongs to a vulnerable population (per Investigator's judgment) or subjectunable to read or write

Study Design

Total Participants: 2228
Treatment Group(s): 2
Primary Treatment: FFR guided revascularization
Phase:
Study Start date:
November 09, 2021
Estimated Completion Date:
May 31, 2025

Study Description

The FAST III is a randomized controlled, open-label, multicenter, international, non-inferiority, strategy trial of a vFFR guided strategy as compared to a FFR guided strategy to guide coronary revascularization in 2228 subjects with intermediate coronary artery lesions.

Patients are screened for inclusion/exclusion criteria after the indication for coronary catheterization is established. After providing informed consent, patients are enrolled. Randomization is performed in the randomization module of the EDC system with an allocation ratio of 1:1 and stratification by center. The primary endpoint is a composite of all-cause death, any myocardial infarction, or any revascularization at 1 year post-randomization.

All deaths and major cardiovascular events, including the individual components of primary and secondary endpoints are adjudicated by an independent Clinical Events Committee (CEC), using standardized definitions. An independent Data and Safety Monitoring Board (DSMB) will formally review the accumulating data to ensure there is no avoidable increased risk for harm to participants. The FAST III trial is performed in accordance with the Declaration of Helsinki, Good Clinical Practice (GCP), ISO 14155:2020, EC requirements and country specific regulations.

Connect with a study center

  • Clinique St Martin

    Caen,
    France

    Active - Recruiting

  • Institut Cardiovasculaire de Grenoble

    Grenoble,
    France

    Site Not Available

  • CHU LILLE - Institut Cœur Poumon

    Lille,
    France

    Active - Recruiting

  • Hôpital de la Croix Rousse, hospices civils de lyon

    Lyon,
    France

    Active - Recruiting

  • Hôpital Privé Jacques Cartier

    Massy,
    France

    Site Not Available

  • Clinique les Fontaines

    Melun,
    France

    Active - Recruiting

  • Clinique Saint Hilaire

    Rouen,
    France

    Active - Recruiting

  • Herz- und Diabeteszentrum NRW

    Bad Oeynhausen,
    Germany

    Active - Recruiting

  • Charité- Campus Benjamin Franklin

    Berlin,
    Germany

    Active - Recruiting

  • Unfallkrankenhaus Berlin

    Berlin,
    Germany

    Active - Recruiting

  • Universitatsklinikum Dusseldorf

    Düsseldorf,
    Germany

    Site Not Available

  • Marienhaus Klinikum

    Neuwied,
    Germany

    Active - Recruiting

  • SHG Klinik Völklingen

    Völklingen,
    Germany

    Active - Recruiting

  • Mater Private Cork

    Cork,
    Ireland

    Active - Recruiting

  • Beaumont Hospital

    Dublin,
    Ireland

    Site Not Available

  • Mater Private Dublin

    Dublin,
    Ireland

    Active - Recruiting

  • St James Hospital

    Dublin,
    Ireland

    Active - Recruiting

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo,
    Italy

    Active - Recruiting

  • AOU di Ferrara (Ospedale Sant'Anna)

    Cona,
    Italy

    Active - Recruiting

  • Cardiologia Ospedale Dell' Angelo

    Mestre,
    Italy

    Active - Recruiting

  • Humanitas Research Hospital

    Milan,
    Italy

    Active - Recruiting

  • Policlinico San Donato

    Milan,
    Italy

    Active - Recruiting

  • Pineta Grande Hospital

    Naples,
    Italy

    Site Not Available

  • Ospedale Maggiore della Carità

    Novara,
    Italy

    Active - Recruiting

  • AOU Verona

    Verona,
    Italy

    Site Not Available

  • Cardiologia Ospedale San Bortolo

    Vicenza,
    Italy

    Active - Recruiting

  • Tergooi MC

    Blaricum,
    Netherlands

    Active - Recruiting

  • Amphia Ziekenhuis

    Breda,
    Netherlands

    Active - Recruiting

  • Albert Schweitzer

    Dordrecht,
    Netherlands

    Active - Recruiting

  • Erasmus University Medical Center

    Rotterdam,
    Netherlands

    Active - Recruiting

  • UMCU

    Utrecht,
    Netherlands

    Active - Recruiting

  • Hospital Univeritario A Coruna

    A Coruña,
    Spain

    Active - Recruiting

  • Hospital Clinic

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital del Mar

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Universitario de Leon

    León,
    Spain

    Site Not Available

  • Hospital Universitario de la Princesa

    Madrid,
    Spain

    Active - Recruiting

  • La Paz

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Central de Asturias

    Oviedo,
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Valladolid

    Valladolid,
    Spain

    Active - Recruiting

  • Royal Victoria Hospital

    Belfast,
    United Kingdom

    Site Not Available

  • Royal Sussex County Hospital

    Brighton,
    United Kingdom

    Active - Recruiting

  • Golden Jubilee National Hospital

    Glasgow,
    United Kingdom

    Active - Recruiting

  • John Radcliffe Hospital

    Oxford,
    United Kingdom

    Active - Recruiting

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