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

NCT04931771 | Unknown DMC

• 1 other identifier: ECRI-15
• Study Type: interventional
• Target: 2,228
• Locations: 7 countries
• Sites: 43

Brief 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).

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; Intermediate coronary lesion; Coronary physiology; vFFR

Outcome Measures

Primary Outcomes (1)

• Rate of the composite of all-cause death, any myocardial infarction, or any revascularization

  Procedural myocardial infarction (MI) is adjudicated according to the ARC-2 consensus and spontaneous MI according to the 4th Universal definition of MI.

  1 year

Secondary Outcomes (7)

• Rate of patient-oriented composite endpoint (POCE) defined as all-cause death, any stroke, any myocardial infarction, and any revascularization

  1 year

• Rate of device-oriented composite endpoint (DOCE) defined as the composite of cardiovascular death, target-vessel MI, clinically indicated repeat revascularization of the target lesion

  1 year

• Rate of study-oriented composite endpoint (SOCE) defined as the composite of cardiovascular death, study-vessel or target vessel MI, or study-vessel or target vessel revascularization

  1 year

• Rate of target-vessel failure defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-vessel revascularization

  1 year

• Rate of target-lesion failure defined as a composite of cardiac death, target vessel myocardial infarction, or clinically indicated target-lesion revascularization

  1 year

Other Outcomes (5)

• Quality of life (QoL) using the Seattle Angina Questionnaire

  1 month and 1 year

• Procedural time

  Baseline

• Total contrast volume

  Baseline

Study Arms (2)

vFFR guided revascularization

EXPERIMENTAL

Device: vFFR guided revascularization

FFR guided revascularization

ACTIVE COMPARATOR

Device: FFR guided revascularization

Interventions

vFFR guided revascularization DEVICE

3D-angio-based vessel FFR (CAAS, Pie Medical Imaging, Maastricht, The Netherlands) uses 3-Dimensional Quantitative Coronary Angiography (3D-QCA) for functional assessment of coronary stenosis. vFFR is calculated using two angiographic views with at least 30 degrees difference in rotation/angulation to generate the 3D reconstruction of the coronary artery.

vFFR guided revascularization

FFR guided revascularization DEVICE

Fractional flow reserve (FFR) is a technique used in coronary catheterization to measure pressure differences across a coronary artery stenosis (narrowing, usually due to atherosclerosis) to determine the likelihood that the stenosis impedes oxygen delivery to the heart muscle (myocardial ischemia)

FFR guided revascularization

Eligibility Criteria

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

You may qualify if:

• The patient must be ≥18 years of age
• Presenting with silent ischemia, stable angina, or non-ST-elevation acute coronary syndrome (NSTE-ACS)
• Coronary artery disease with at least one native artery in which the stenosis severity is questionable (typically 30-80% stenosis)
• FFR assessment and vFFR assessment feasible
• The patient is willing and able to cooperate with study procedures and follow-up until study completion
• Subject is able to confirm understanding of risks, benefits and treatment alternatives and he/she provides informed consent prior to any protocol-related procedure, as approved by the appropriate Ethics Committee

You may not qualify if:

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

Sponsors & Collaborators

• ECRI bv: lead
• Siemens Healthineers AG: collaborator
• Pie Medical Imaging: collaborator

Study Sites (43)

Clinique St Martin

Caen, France

RECRUITING

Institut Cardiovasculaire de Grenoble

Grenoble, France

NOT YET RECRUITING

CHU LILLE - Institut Cœur Poumon

Lille, France

RECRUITING

Hôpital de la Croix Rousse, hospices civils de lyon

Lyon, France

RECRUITING

Hôpital Privé Jacques Cartier

Massy, France

NOT YET RECRUITING

Clinique les Fontaines

Melun, France

RECRUITING

Clinique Saint Hilaire

Rouen, France

RECRUITING

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, Germany

RECRUITING

Charité- Campus Benjamin Franklin

Berlin, Germany

RECRUITING

Unfallkrankenhaus Berlin

Berlin, Germany

RECRUITING

Universitatsklinikum Dusseldorf

Düsseldorf, Germany

NOT YET RECRUITING

Marienhaus Klinikum

Neuwied, Germany

RECRUITING

SHG Klinik Völklingen

Völklingen, Germany

RECRUITING

Mater Private Cork

Cork, Ireland

RECRUITING

Beaumont Hospital

Dublin, Ireland

WITHDRAWN

Mater Private Dublin

Dublin, Ireland

RECRUITING

St James Hospital

Dublin, Ireland

RECRUITING

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, Italy

RECRUITING

AOU di Ferrara (Ospedale Sant'Anna)

Cona, Italy

RECRUITING

Cardiologia Ospedale Dell' Angelo

Mestre, Italy

RECRUITING

Humanitas Research Hospital

Milan, Italy

RECRUITING

Policlinico San Donato

Milan, Italy

RECRUITING

Pineta Grande Hospital

Naples, Italy

NOT YET RECRUITING

Ospedale Maggiore della Carità

Novara, Italy

RECRUITING

AOU Verona

Verona, Italy

WITHDRAWN

Cardiologia Ospedale San Bortolo

Vicenza, Italy

RECRUITING

Tergooi MC

Blaricum, Netherlands

RECRUITING

Amphia Ziekenhuis

Breda, Netherlands

RECRUITING

Albert Schweitzer

Dordrecht, Netherlands

RECRUITING

Erasmus University Medical Center

Rotterdam, Netherlands

RECRUITING

UMCU

Utrecht, Netherlands

RECRUITING

Hospital Univeritario A Coruna

A Coruña, Spain

RECRUITING

Hospital Clinic

Barcelona, Spain

RECRUITING

Hospital del Mar

Barcelona, Spain

RECRUITING

Hospital Universitario de Leon

León, Spain

NOT YET RECRUITING

Hospital Universitario de la Princesa

Madrid, Spain

RECRUITING

La Paz

Madrid, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Spain

RECRUITING

Hospital Clinico Universitario de Valladolid

Valladolid, Spain

RECRUITING

Royal Victoria Hospital

Belfast, United Kingdom

WITHDRAWN

Royal Sussex County Hospital

Brighton, United Kingdom

RECRUITING

Golden Jubilee National Hospital

Glasgow, United Kingdom

RECRUITING

John Radcliffe Hospital

Oxford, United Kingdom

RECRUITING

Related Publications (1)

• Scoccia A, Byrne RA, Banning AP, Landmesser U, Van Belle E, Amat-Santos IJ, Sabate M, Tijssen JGP, Spitzer E, Daemen J. Fractional flow reserve or 3D-quantitative-coronary-angiography based vessel-FFR guided revascularization. Rationale and study design of the prospective randomized fast III trial. Am Heart J. 2023 Jun;260:1-8. doi: 10.1016/j.ahj.2023.02.003. Epub 2023 Feb 14.

  PMID: 36796573 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

• Ernest Spitzer, MD

  European Cardiovascular Research Institute

  STUDY DIRECTOR

Central Study Contacts

Ernest Spitzer, MD

CONTACT

+31102062828; E.Spitzer@ECRI-Trials.com

Monique Schuijer, PhD

CONTACT

+31102062828; MSchuijer@cardialysis.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: June 18, 2021
• Study Start: November 9, 2021
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6); ES (8); IE (4); FR (7); GB (4); IT (9); NL (5)