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

Recruiting now · Not applicable

Conditions studied: Coronary Artery Disease, Chronic Coronary Syndrome, Acute Coronary Syndrome

In brief

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.

Key facts

Study ID

NCT07329699

Run by

Samsung Medical Center

People needed

2100

Starts

2026-03-18

Expected to finish

2029-12-31

Last updated by the study team

2026-04-23

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must be at least 19 years of age
• Eligible for coronary angiography and/or percutaneous coronary intervention.
• Chronic coronary syndrome or acute coronary syndrome (non-culprit vessels only)
• 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).
• Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.

You may not qualify if…

• Patients unable to provide informed consent
• Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents and drug-coated balloons
• Patients with coronary artery bypass grafting
• Patients who have non-cardiac co-morbid conditions with life expectancy <1 year
• Patients with cardiogenic shock or cardiac arrest
• Patients with severe left ventricular systolic dysfunction (ejection fraction <30%)
• Patients with severe valvular heart disease requiring open heart surgery
• Pregnant or lactating women
• 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 it is running

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

Full record on ClinicalTrials.gov

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