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COMPLETED
NCT04931771
NA

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

Sponsor: ECRI bv

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2235

Start Date

2021-11-09

Completion Date

2025-12-17

Last Updated

2026-06-23

Healthy Volunteers

No

Interventions

DEVICE

vFFR guided revascularization

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.

DEVICE

FFR guided revascularization

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)

Locations (40)

Clinique St Martin

Caen, France

Institut Cardiovasculaire de Grenoble

Grenoble, France

CHU LILLE - Institut Cœur Poumon

Lille, France

Hôpital de la Croix Rousse, hospices civils de lyon

Lyon, France

Hôpital Privé Jacques Cartier

Massy, France

Clinique les Fontaines

Melun, France

Clinique Saint Hilaire

Rouen, France

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, Germany

Charité- Campus Benjamin Franklin

Berlin, Germany

Unfallkrankenhaus Berlin

Berlin, Germany

Universitatsklinikum Dusseldorf

Düsseldorf, Germany

Marienhaus Klinikum

Neuwied, Germany

SHG Klinik Völklingen

Völklingen, Germany

Mater Private Cork

Cork, Ireland

Mater Private Dublin

Dublin, Ireland

St James Hospital

Dublin, Ireland

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, Italy

AOU di Ferrara (Ospedale Sant'Anna)

Cona, Italy

Cardiologia Ospedale Dell' Angelo

Mestre, Italy

Humanitas Research Hospital

Milan, Italy

Policlinico San Donato

Milan, Italy

Pineta Grande Hospital

Naples, Italy

Ospedale Maggiore della Carità

Novara, Italy

Cardiologia Ospedale San Bortolo

Vicenza, Italy

Tergooi MC

Blaricum, Netherlands

Amphia Ziekenhuis

Breda, Netherlands

Albert Schweitzer

Dordrecht, Netherlands

Erasmus University Medical Center

Rotterdam, Netherlands

UMCU

Utrecht, Netherlands

Hospital Univeritario A Coruna

A Coruña, Spain

Hospital Clinic

Barcelona, Spain

Hospital del Mar

Barcelona, Spain

Hospital Universitario de Leon

León, Spain

Hospital Universitario de la Princesa

Madrid, Spain

La Paz

Madrid, Spain

Hospital Universitario Central de Asturias

Oviedo, Spain

Hospital Clinico Universitario de Valladolid

Valladolid, Spain

Royal Sussex County Hospital

Brighton, United Kingdom

Golden Jubilee National Hospital

Glasgow, United Kingdom

John Radcliffe Hospital

Oxford, United Kingdom