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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
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

Full criteria on ClinicalTrials.gov

Sites (40)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Herz- und Diabeteszentrum NRW
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Bad OeynhausenGermanyUnknown status
Unfallkrankenhaus Berlin
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BerlinGermanyUnknown status
Charité Campus Benjamin Franklin
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BerlinGermanyUnknown status
Universitätsklinikum Düsseldorf
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DüsseldorfGermanyUnknown status
Marienhaus Klinikum
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NeuwiedGermanyUnknown status
SHG Klinik Völklingen
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VölklingenGermanyUnknown status
Hospital Univeritario A Coruna
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A CoruñaSpainUnknown status
Hospital Clinic
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BarcelonaSpainUnknown status
Hospital del Mar
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BarcelonaSpainUnknown status
Hospital Universitario De Leon
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LeónSpainUnknown status
Hospital Universitario de la Princesa
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MadridSpainUnknown status
La Paz
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MadridSpainUnknown status
Hospital Universitario Central De Asturias
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OviedoSpainUnknown status
Hospital Clínico Universitario de Valladolid
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ValladolidSpainUnknown status
Clinique St Martin
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CaenFranceUnknown status
Institut Cardiovasculaire de Grenoble
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GrenobleFranceUnknown status
CHU Lille - Institut Cœur Poumon
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LilleFranceUnknown status
Hôpital de la Croix Rousse, hospices civils de lyon
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LyonFranceUnknown status
Hôpital Privé Jacques Cartier
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MassyFranceUnknown status
Clinique les Fontaines
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MelunFranceUnknown status
Clinique Saint-Hilaire
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RouenFranceUnknown status
Royal Sussex County Hospital
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BrightonUnited KingdomUnknown status
Golden Jubilee National Hospital
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GlasgowUnited KingdomUnknown status
John Radcliffe Hospital
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OxfordUnited KingdomUnknown status
Mater Private Cork
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CorkIrelandUnknown status
Mater Private Dublin
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DublinIrelandUnknown status
St James Hospital
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DublinIrelandUnknown status
Azienda Ospedaliera Papa Giovanni XXIII
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BergamoItalyUnknown status
AOU di Ferrara (Ospedale Sant'Anna)
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ConaItalyUnknown status
Cardiologia Ospedale Dell' Angelo
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MestreItalyUnknown status
Humanitas Research Hospital
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MilanItalyUnknown status
Policlinico San Donato
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MilanItalyUnknown status
Pineta Grande Hospital
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NaplesItalyUnknown status
Ospedale Maggiore della Carità
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NovaraItalyUnknown status
Cardiologia Ospedale San Bortolo
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VicenzaItalyUnknown status
Tergooi MC
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BlaricumNetherlandsUnknown status
Amphia Ziekenhuis
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BredaNetherlandsUnknown status
Albert Schweitzer
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DordrechtNetherlandsUnknown status
Erasmus University Medical Center
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RotterdamNetherlandsUnknown status
UMCU
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UtrechtNetherlandsUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.