NCT04931771Completed
Fractional Flow Reserve or 3D-Quantitative-Coronary-Angiography Based Vessel-FFR Guided Revascularization
Source: ClinicalTrials.gov · Last updated 23 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 2235 (actual)
- First submitted
- 7 Jun 2021
- Start date
- 9 Nov 2021
- Primary completion date
- 17 Dec 2025
- Lead sponsor
- ECRI bv
- Diseases
- Coronary artery disease
- NCT number
- NCT04931771
What you commit to
- Study type: Interventional
- Participants enrolled: 2235
- From 9 Nov 2021 to the primary completion date, 17 Dec 2025
- 40 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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.
- Known untreated severe valvular heart disease
- History of cardiac allograft transplantation
- 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
Other
- Presence of thrombus in intermediate target lesion.
- Target lesion is located in or supplied by an arterial or venous bypass graft
- 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.
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (40)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Herz- und Diabeteszentrum NRW Coordinator of this site? Confirm its status | Bad Oeynhausen | Germany | Unknown status |
| Unfallkrankenhaus Berlin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Charité Campus Benjamin Franklin Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Universitätsklinikum Düsseldorf Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
| Marienhaus Klinikum Coordinator of this site? Confirm its status | Neuwied | Germany | Unknown status |
| SHG Klinik Völklingen Coordinator of this site? Confirm its status | Völklingen | Germany | Unknown status |
| Hospital Univeritario A Coruna Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Hospital Clinic Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario De Leon Coordinator of this site? Confirm its status | León | Spain | Unknown status |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Central De Asturias Coordinator of this site? Confirm its status | Oviedo | Spain | Unknown status |
| Hospital Clínico Universitario de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Unknown status |
| Clinique St Martin Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| Institut Cardiovasculaire de Grenoble Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| CHU Lille - Institut Cœur Poumon Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Hôpital de la Croix Rousse, hospices civils de lyon Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Hôpital Privé Jacques Cartier Coordinator of this site? Confirm its status | Massy | France | Unknown status |
| Clinique les Fontaines Coordinator of this site? Confirm its status | Melun | France | Unknown status |
| Clinique Saint-Hilaire Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Royal Sussex County Hospital Coordinator of this site? Confirm its status | Brighton | United Kingdom | Unknown status |
| Golden Jubilee National Hospital Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| John Radcliffe Hospital Coordinator of this site? Confirm its status | Oxford | United Kingdom | Unknown status |
| Mater Private Cork Coordinator of this site? Confirm its status | Cork | Ireland | Unknown status |
| Mater Private Dublin Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| St James Hospital Coordinator of this site? Confirm its status | Dublin | Ireland | Unknown status |
| Azienda Ospedaliera Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Unknown status |
| AOU di Ferrara (Ospedale Sant'Anna) Coordinator of this site? Confirm its status | Cona | Italy | Unknown status |
| Cardiologia Ospedale Dell' Angelo Coordinator of this site? Confirm its status | Mestre | Italy | Unknown status |
| Humanitas Research Hospital Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Policlinico San Donato Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Pineta Grande Hospital Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Ospedale Maggiore della Carità Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
| Cardiologia Ospedale San Bortolo Coordinator of this site? Confirm its status | Vicenza | Italy | Unknown status |
| Tergooi MC Coordinator of this site? Confirm its status | Blaricum | Netherlands | Unknown status |
| Amphia Ziekenhuis Coordinator of this site? Confirm its status | Breda | Netherlands | Unknown status |
| Albert Schweitzer Coordinator of this site? Confirm its status | Dordrecht | Netherlands | Unknown status |
| Erasmus University Medical Center Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Unknown status |
| UMCU Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
Related publications
- Angiography-Based Physiology to Guide Coronary Revascularization.N Engl J Med · 2026 · PMID 41910382
This page is information, not medical advice. Discuss any trial with your doctor.