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Guided revascularization for coronary artery disease using advanced imaging techniques

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

Not applicable Interventional ECRI bv · NCT04931771

This study is testing whether a new imaging method can help guide heart procedures better than the traditional method for people with certain types of blocked arteries.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment2228 (estimated)
Ages18 Years and up
SexAll
SponsorECRI bv Industry-sponsored
Locations43 sites (Caen and 42 other locations)
Trial IDNCT04931771 on ClinicalTrials.gov

What this trial studies

The FAST III trial is a randomized controlled trial comparing two strategies for guiding coronary revascularization in patients with intermediate coronary artery lesions: vessel fractional flow reserve (vFFR) and traditional fractional flow reserve (FFR). A total of 2228 participants will be enrolled and followed for up to 12 months to assess the effectiveness of these approaches in preventing major cardiovascular events. The trial will take place across approximately 35 sites in seven European countries, ensuring a diverse patient population. The primary endpoint focuses on all-cause death, myocardial infarction, and revascularization within one year post-randomization.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with stable angina, silent ischemia, or non-ST-elevation acute coronary syndrome and questionable stenosis severity.

Not a fit: Patients presenting with ST-elevation myocardial infarction or severe hemodynamic instability are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the precision of coronary revascularization strategies, potentially leading to better patient outcomes.

How similar studies have performed: Previous studies have shown promise with similar imaging-guided approaches, suggesting potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. The patient must be ≥18 years of age
2. Presenting with silent ischemia, stable angina, or non-ST-elevation acute coronary syndrome (NSTE-ACS)
3. Coronary artery disease with at least one native artery in which the stenosis severity is questionable (typically 30-80% stenosis)
4. FFR assessment and vFFR assessment feasible
5. The patient is willing and able to cooperate with study procedures and follow-up until study completion
6. 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

Exclusion Criteria:

1. ST-elevation myocardial infarction (STEMI) at presentation
2. 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
3. Any target vessel with a distal Thrombolysis In Myocardial Infarction (TIMI) flow \<3.
4. Presence of thrombus in intermediate target lesion.
5. Known untreated severe valvular heart disease
6. Target lesion is located in or supplied by an arterial or venous bypass graft
7. History of cardiac allograft transplantation
8. Aorto-ostial lesions with an estimated diameter stenosis \>50%
9. Severe tortuosity precluding the acquisitions of 2 orthogonal projections of the target vessel with minimal overlap or foreshortening.
10. Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or adenosine
11. Non-cardiac co-morbidities with a life expectancy less than 1 year
12. 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
13. Women of childbearing potential who do not have a negative pregnancy test within 24 hours before the procedure
14. Subject belongs to a vulnerable population (per Investigator's judgment) or subject unable to read or write

Where this trial is running

Caen and 42 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Coronary Artery DiseaseCoronary artery diseaseIntermediate coronary lesionCoronary physiologyvFFR
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.