AI-driven Medipixel fractional flow reserve to guide PCI

Artificial Intelligence-Driven Angiography-Based Fractional Flow Reserve Versus Invasive Fractional Flow Reserve-Guided PCI

This test checks whether an AI-based, angiography-derived Medipixel FFR method can guide PCI as safely and effectively as standard invasive pressure-wire FFR in adults with coronary artery disease.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 2100 (estimated)
• Ages: 19 Years and up
• Sex: All
• Sponsor: Samsung Medical Center (other)
• Locations: 23 sites (Seoul, Select State and 22 other locations)
• Trial ID: NCT07329699 on ClinicalTrials.gov

What this trial studies

AIM-FFR is a prospective, multicenter, open-label, randomized non-inferiority trial comparing MPFFR-guided percutaneous coronary intervention with invasive pressure-wire FFR-guided PCI. Adults with chronic coronary syndrome or acute coronary syndrome (non-culprit vessels) and visually intermediate coronary stenoses eligible for angiography/PCI will be randomized to guidance by the AI angiography-derived MPFFR or by invasive FFR. MPFFR is a wire-free, AI-enabled computation of fractional flow reserve from routine angiograms designed to reduce the need for pressure wires, hyperemia, and prolonged procedure time. The trial will compare decision-making and patient outcomes between the two guidance strategies across several tertiary centers in South Korea.

Who should consider this trial

Good fit: Adults aged 19 or older with coronary artery disease (chronic or ACS non-culprit vessels), visually intermediate lesions (roughly 40–90% stenosis) and who are eligible for coronary angiography and/or PCI are ideal candidates.

Not a fit: Patients with prior coronary artery bypass grafting, cardiogenic shock, non-cardiac conditions with life expectancy under one year, inability to consent, or known intolerance to required antiplatelet or device components are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, MPFFR could let more patients receive physiologic lesion assessment without pressure wires or hyperemia, shortening procedures and making FFR-guided decisions easier to use.

How similar studies have performed: Other angiography-derived FFR methods such as QFR have shown reasonable diagnostic accuracy and QFR-guided PCI improved outcomes versus angiography-guided PCI, but MPFFR is a newer AI-driven variant that has less randomized outcome data so far.

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

Where this trial is running

Seoul, Select State and 22 other locations

• Korea University Anam Hospital — Seoul, Select State, South Korea (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)

Study contacts

• Principal investigator: Joo Myung Lee, MD, MPH, PhD — Samsung Medical Center
• Study coordinator: Joo Myung Lee, MD, MPH, PhD

Conditions: Coronary Artery Disease, Chronic Coronary Syndrome, Acute Coronary Syndrome, Coronary artery stenosis, Fractional flow reserve, Prognosis