Actively Recruiting
Artificial Intelligence-Driven Medipixel Fractional Flow Reserve Versus Invasive Fractional Flow Reserve-Guided PCI Trial (AIM-FFR Trial)
Led by Samsung Medical Center · Updated on 2026-04-23
2100
Participants Needed
23
Research Sites
197 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
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.
CONDITIONS
Official 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
- Diagnosis of 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 2.5 mm and visually assessed stenosis with uncertain severity (typically 40-90% diameter stenosis)
- Able to understand risks, benefits, and treatment options and able to 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 co-morbid 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
- Target lesions in culprit vessel of ST-elevation myocardial infarction (non-culprit vessels can be enrolled)
- Chronic total occlusion (target lesions in vessels without chronic total occlusion can be enrolled)
- Ostial stenosis in left main coronary artery or right coronary artery
- Severe tortuosity of any target vessel
- Severe overlap in the stenosed segment
- Poor image quality preventing identification of vessel contours
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
S
Seung Hun Lee, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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