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Recruiting Not applicable

Artificial Intelligence-Driven Medipixel Fractional Flow Reserve Versus Invasive Fractional Flow Reserve-Guided PCI Trial (AIM-FFR Trial)

NCT07329699 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2026-03-18
Last updated
2026-04-23

Condition(s) studied

Coronary Artery DiseaseChronic Coronary SyndromeAcute Coronary Syndrome

Investigational drug(s) / intervention(s)

MPFFR or Invasive FFR

MPFFR or Invasive FFR: Functionally significant stenosis will be defined as MPFFR≤0.80 or FFR≤0.80. For lesions with MPFFR≤0.80 or FFR≤0.80, PCI will be recommended under current guidelines, however, final decision regarding PCI will be at the discretion of operators. In the MPFFR-guided PCI group, on-site MPFFR value will be used in decision making of revascularization. If PCI is not performed for lesions with MPFFR≤0.80 or FFR≤0.80, the specific reasons will be collected in electronic case report form. For lesions with MPFFR\>0.80 or FFR\>0.80, PCI will be deferred.

Study summary

The AIM-FFR trial is a prospective, multi-center, open-label, randomized controlled, non-inferiority trial. The current trial will evaluate non-inferiority of MPFFR-guided PCI, compared with invasive FFR-guided PCI in patients with coronary artery disease.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Subject must be at least 19 years of age 2. Eligible for coronary angiography and/or percutaneous coronary intervention. 3. Chronic coronary syndrome or acute coronary syndrome (non-culprit vessels only) 4. Coronary artery disease in one or more native major epicardial vessels or their branches with reference vessel diameter of at least 2.5mm and with visually assessed coronary stenosis in which the physiological severity of the lesion is questionable (typically 40-90% diameter stenosis). 5. Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily. Exclusion Criteria: 1. Patients unable to provide informed consent 2. Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents and drug-coated balloons 3. Patients with coronary artery bypass grafting 4. Patients who have non-cardiac co-morbid conditions with life expectancy \<1 year 5. Patients with cardiogenic shock or cardiac arrest 6. Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%) 7. Patients with severe valvular heart disease requiring open heart surgery 8. Pregnant or lactating women 9. Angiographic exclusion criteria * Culprit vessel of patients with ST-elevation myocardial infarction (target lesions in non-culprit vessel can be enrolled) * Chronic total occlusion (target lesions in vessels without chronic total occlusion can be enrolled) * Ostial stenosis in left man coronary artery or right coronary artery * Severe tortuosity of any target vessel * Severe overlap in the stenosed segment * Poor image quality precluding identification of vessel contours

Primary outcome measure(s)

  • Major adverse cardiac events (MACE) — 1 year after last patient enrollment
    a composite of death from any causes, non-fatal myocardial infarction \[MI\], and clinically indicated unplanned revascularization

Trial sites (23)

FacilityCityRegionStatus
Korea University Anam Hospital Seoul Select State Recruiting
Inje University Haeundae Paik Hospital Busan South Korea Recruiting
Changwon Fatima Hospital Changwon South Korea Recruiting
Gyeongsang National University Changwon Hospital Changwon South Korea Recruiting
Keimyung University Dongsan Hospital Daegu South Korea Recruiting
Kyungpook National University Hospital Daegu South Korea Recruiting
Chonnam National University Hospital, Chonnam National University Medical School Gwangju South Korea Recruiting
Chung-Ang University Gwangmyeong Hospital Gwangmyeong South Korea Recruiting
CHA Bundang Medical Center Gyeonggi-do South Korea Recruiting
Wonkwang University Hospital Iksan South Korea Recruiting
Inje University College of Medicine, Ilsan Paik Hospital Ilsan South Korea Recruiting
Gachon University Gil Medical Center Incheon South Korea Recruiting
International St. Mary's Hospital Incheon South Korea Recruiting
Gyeongsang National University Hospital Jinju South Korea Recruiting
Seoul National University Bundang Hospital Seongnam South Korea Recruiting
Samsung Medical Center Seoul South Korea Recruiting
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine Seoul South Korea Recruiting
Korea University Guro Hospital Seoul South Korea Recruiting
Seoul National University Boramae Medical Center Seoul South Korea Recruiting
Ajou University Hospital Suwon South Korea Recruiting
Uijeongbu ST. Mary's Hospital Uijeongbu-si South Korea Recruiting
Ulsan University Hospital Ulsan South Korea Recruiting
Wonju Severance Christian Hospital Wŏnju South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07329699 on ClinicalTrials.gov ↗ ← All trials in South Korea