NCT07329699 Artificial Intelligence-Driven Medipixel Fractional Flow Reserve Versus Invasive Fractional Flow Reserve-Guided PCI Trial (AIM-FFR Trial)
| NCT ID | NCT07329699 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Samsung Medical Center |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,100 participants |
| Start Date | 2026-03-18 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,100 participants in total. It began in 2026-03-18 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Joo Myung Lee, MD, MPH, PhD
PRINCIPAL INVESTIGATOR
Samsung Medical Center
Frequently Asked Questions
Who can join the NCT07329699 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07329699 currently recruiting?
Yes, NCT07329699 is actively recruiting participants. Contact the research team at drone80@hanmail.net for enrollment information.
Where is the NCT07329699 trial being conducted?
This trial is being conducted at Seoul, South Korea, Busan, South Korea, Changwon, South Korea, Changwon, South Korea and 11 additional locations.
Who is sponsoring the NCT07329699 clinical trial?
NCT07329699 is sponsored by Samsung Medical Center. The principal investigator is Joo Myung Lee, MD, MPH, PhD at Samsung Medical Center. The trial plans to enroll 2,100 participants.