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

NCT04931771 | Completed DMC

• 1 other identifier: ECRI-15
• Study Type: interventional
• Target: 2,235
• Locations: 7 countries
• Sites: 40

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 (40)

Clinique St Martin

Caen, France

Location

Institut Cardiovasculaire de Grenoble

Grenoble, France

Location

CHU LILLE - Institut Cœur Poumon

Lille, France

Location

Hôpital de la Croix Rousse, hospices civils de lyon

Lyon, France

Location

Hôpital Privé Jacques Cartier

Massy, France

Location

Clinique les Fontaines

Melun, France

Location

Clinique Saint Hilaire

Rouen, France

Location

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, Germany

Location

Charité- Campus Benjamin Franklin

Berlin, Germany

Location

Unfallkrankenhaus Berlin

Berlin, Germany

Location

Universitatsklinikum Dusseldorf

Düsseldorf, Germany

Location

Marienhaus Klinikum

Neuwied, Germany

Location

SHG Klinik Völklingen

Völklingen, Germany

Location

Mater Private Cork

Cork, Ireland

Location

Mater Private Dublin

Dublin, Ireland

Location

St James Hospital

Dublin, Ireland

Location

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, Italy

Location

AOU di Ferrara (Ospedale Sant'Anna)

Cona, Italy

Location

Cardiologia Ospedale Dell' Angelo

Mestre, Italy

Location

Humanitas Research Hospital

Milan, Italy

Location

Policlinico San Donato

Milan, Italy

Location

Pineta Grande Hospital

Naples, Italy

Location

Ospedale Maggiore della Carità

Novara, Italy

Location

Cardiologia Ospedale San Bortolo

Vicenza, Italy

Location

Tergooi MC

Blaricum, Netherlands

Location

Amphia Ziekenhuis

Breda, Netherlands

Location

Albert Schweitzer

Dordrecht, Netherlands

Location

Erasmus University Medical Center

Rotterdam, Netherlands

Location

UMCU

Utrecht, Netherlands

Location

Hospital Univeritario A Coruna

A Coruña, Spain

Location

Hospital Clinic

Barcelona, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Universitario de Leon

León, Spain

Location

Hospital Universitario de la Princesa

Madrid, Spain

Location

La Paz

Madrid, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, Spain

Location

Royal Sussex County Hospital

Brighton, United Kingdom

Location

Golden Jubilee National Hospital

Glasgow, United Kingdom

Location

John Radcliffe Hospital

Oxford, United Kingdom

Location

Related Publications (2)

• Daemen J, van der Eijk JA, Barbierato M, Byrne RA, Canova P, De Maria GL, Van Belle E, Amat-Santos I, Mangieri A, Hovasse T, Sabate M, Margey R, Biscaglia S, Rivero F, D'Amario D, Abdelwahed YS, Oemrawsingh RM, Moreno R, Cockburn J, Testa L, de Vries T, Landmesser U, Banning AP, Tijssen JGP, Spitzer E; FAST III Investigators. Angiography-Based Physiology to Guide Coronary Revascularization. N Engl J Med. 2026 Mar 29. doi: 10.1056/NEJMoa2601841. Online ahead of print.

  PMID: 41910382 RESULT

• 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

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: December 17, 2025
• Study Completion: December 17, 2025
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (6); ES (8); FR (7); GB (3); IT (8); NL (5); IE (3)