Artificial Intelligence-Driven Angiography-Based Fractional Flow Reserve Versus Invasive Fractional Flow Reserve-Guided PCI
Trial ID: NCT07329699
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2026-03-18
Completion date: 2029-12-31
Sponsor: Samsung Medical Center
Collaborators: Chonnam National University Hospital; Seoul National University Bundang Hospital; Chung-Ang University Gwangmyeong Hospital; The Catholic University of Korea; Keimyung University Dongsan Medical Center; Wonju Severance Christian Hospital; SMG-SNU Boramae Medical Center; Kangbuk Samsung Hospital, Sungkyunkwan University; Korea University Guro Hospital; Inje University Ilsan Paik Hospital; International St. Mary's Hospital; Kyungpook National University Hospital; Korea University Anam Hospital; Ajou University School of Medicine; Changwon Patima Hospital; Bundang CHA Hospital; Ulsan University Hospital; Gachon University Gil Medical Center; Inje University Haeundae Paik Hospital; Gyeongsang National University Changwon Hospital; Wonkwang University Hospital
Conditions: Coronary Artery Disease; Chronic Coronary Syndrome; Acute Coronary Syndrome
Interventions: MPFFR or Invasive FFR
Locations: Korea University Anam Hospital; Inje University Haeundae Paik Hospital; Changwon Fatima Hospital; Gyeongsang National University Changwon Hospital; Keimyung University Dongsan Hospital; Kyungpook National University Hospital; Chonnam National University Hospital, Chonnam National University Medical School; Chung-Ang University Gwangmyeong Hospital; CHA Bundang Medical Center; Wonkwang University Hospital; Inje University College of Medicine, Ilsan Paik Hospital; Gachon University Gil Medical Center; International St. Mary's Hospital; Gyeongsang National University Hospital; Seoul National University Bundang Hospital; Samsung Medical Center; Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine; Korea University Guro Hospital; Seoul National University Boramae Medical Center; Ajou University Hospital; Uijeongbu ST. Mary's Hospital; Ulsan University Hospital; Wonju Severance Christian Hospital
Countries: South Korea; South Korea; South Korea; South Korea; South Korea; South Korea; South Korea; South Korea; South Korea; South Korea; South Korea; South Korea; South Korea; South Korea; South Korea; South Korea; South Korea; South Korea; South Korea; South Korea; South Korea; South Korea; South Korea
Enrollment: 2100
Age range: 19 Years - None
Sex: ALL

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 criteria:
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

Outcomes:
Major adverse cardiac events (MACE)