Actively Recruiting
Artificial Intelligence-Driven Angiography-Based Fractional Flow Reserve Versus Invasive Fractional Flow Reserve-Guided PCI
Led by Samsung Medical Center · Updated on 2026-04-23
2100
Participants Needed
23
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
Samsung Medical Center
Lead Sponsor
C
Chonnam National University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of an artificial intelligence-driven angiography-based fractional flow reserve (MPFFR) compared with invasive fractional flow reserve (FFR) to guide percutaneous coronary intervention (PCI) in patients with coronary artery disease. This multi-center, randomized controlled trial aims to determine if MPFFR-guided PCI is not inferior to invasive FFR-guided PCI in terms of clinical outcomes. The study addresses limitations of current FFR methods, such as the need for pressure wires and drug-induced hyperemia, by testing a faster, automated AI-based alternative. Participants will be randomly assigned to one of two groups: the MPFFR-guided PCI group or the invasive FFR-guided PCI group. In the MPFFR group, AI software analyzes angiographic images to measure blood flow reserve without manual segmentation, with PCI recommended for lesions showing MPFFR values of 0.80 or less. In the invasive FFR group, a pressure wire and drugs are used to measure FFR, with PCI recommended for lesions with FFR values of 0.80 or less. Decisions to perform PCI are made by the treating doctors, and reasons for deferral are recorded. During the study, participants will undergo diagnostic coronary angiography followed by the assigned FFR measurement method. Researchers will monitor major adverse cardiac events one year after the last patient enrolls, along with other outcomes such as death, heart attacks, revascularization procedures, and procedure-related measures. The trial includes detailed follow-up to assess safety and effectiveness, with data collected on procedure times, contrast use, and device performance throughout the study period.
CONDITIONS
Brief Title
Artificial Intelligence-Driven Medipixel Fractional Flow Reserve Versus Invasive Fractional Flow Reserve-Guided PCI Trial (AIM-FFR Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 19 years old
- Eligible for coronary angiography and/or percutaneous coronary intervention
- Diagnosed with chronic coronary syndrome or acute coronary syndrome (non-culprit vessels only)
- Coronary artery disease in one or more native major epicardial vessels or branches with vessel diameter at least 2.5mm and visually assessed stenosis of 40-90% with uncertain severity
- Able to understand risks, benefits, and alternatives and provide informed consent voluntarily
You will not qualify if you...
- Unable to provide informed consent
- Known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents and drug-coated balloons
- History of coronary artery bypass grafting
- Non-cardiac conditions with life expectancy less than 1 year
- Cardiogenic shock or cardiac arrest
- Severe left ventricular systolic dysfunction (ejection fraction less than 30%)
- Severe valvular heart disease requiring open heart surgery
- Pregnant or lactating women
- Angiographic exclusions including culprit vessel of ST-elevation myocardial infarction, chronic total occlusion lesions, ostial stenosis of left main or right coronary artery, severe vessel tortuosity, severe overlap in stenosed segment, or poor image quality preventing vessel contour identification
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure with immediate decision making
Participants receive percutaneous coronary intervention (PCI) guided by either artificial intelligence-driven angiography-based fractional flow reserve (MPFFR) or invasive fractional flow reserve (FFR) to assess coronary artery stenosis and guide revascularization decisions.
1 baseline visit and PCI procedure visit
Duration - 1 year after last patient enrollment
Participants are monitored for clinical outcomes including major adverse cardiac events, death, myocardial infarction, revascularization, and safety measures for 1 year after the intervention.
Periodic follow-up visits over 1 year
Trial Site Locations
Total: 23 locations
1
Korea University Anam Hospital
Seoul, Select State, South Korea
Actively Recruiting
2
Inje University Haeundae Paik Hospital
Busan, South Korea
Actively Recruiting
3
Changwon Fatima Hospital
Changwon, South Korea
Actively Recruiting
4
Gyeongsang National University Changwon Hospital
Changwon, South Korea
Actively Recruiting
5
Keimyung University Dongsan Hospital
Daegu, South Korea
Actively Recruiting
6
Kyungpook National University Hospital
Daegu, South Korea
Actively Recruiting
7
Chonnam National University Hospital, Chonnam National University Medical School
Gwangju, South Korea
Actively Recruiting
8
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, South Korea
Actively Recruiting
9
CHA Bundang Medical Center
Gyeonggi-do, South Korea
Actively Recruiting
10
Wonkwang University Hospital
Iksan, South Korea
Actively Recruiting
11
Inje University College of Medicine, Ilsan Paik Hospital
Ilsan, South Korea
Actively Recruiting
12
Gachon University Gil Medical Center
Incheon, South Korea
Actively Recruiting
13
International St. Mary's Hospital
Incheon, South Korea
Actively Recruiting
14
Gyeongsang National University Hospital
Jinju, South Korea
Actively Recruiting
15
Seoul National University Bundang Hospital
Seongnam, South Korea
Actively Recruiting
16
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
17
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
Seoul, South Korea
Actively Recruiting
18
Korea University Guro Hospital
Seoul, South Korea
Actively Recruiting
19
Seoul National University Boramae Medical Center
Seoul, South Korea
Actively Recruiting
20
Ajou University Hospital
Suwon, South Korea
Actively Recruiting
21
Uijeongbu ST. Mary's Hospital
Uijeongbu-si, South Korea
Actively Recruiting
22
Ulsan University Hospital
Ulsan, South Korea
Actively Recruiting
23
Wonju Severance Christian Hospital
Wŏnju, South Korea
Actively Recruiting
Research Team
J
Joo Myung Lee, MD, MPH, PhD
S
Seung Hun Lee, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here