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Artificial Intelligence-Driven Medipixel Fractional Flow Reserve Versus Invasive Fractional Flow Reserve-Guided PCI Trial (AIM-FFR Trial)
Sponsor: Samsung Medical Center
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.
Official title: Artificial Intelligence-Driven Angiography-Based Fractional Flow Reserve Versus Invasive Fractional Flow Reserve-Guided PCI
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2100
Start Date
2026-03-01
Completion Date
2029-12-31
Last Updated
2026-02-12
Healthy Volunteers
No
Interventions
MPFFR or Invasive FFR
Functionally significant stenosis will be defined as MPFFR≤0.80 or FFR≤0.80. For lesions with MPFFR≤0.80 or FFR≤0.80, PCI will be recommended under current guidelines, however, final decision regarding PCI will be at the discretion of operators. In the MPFFR-guided PCI group, on-site MPFFR value will be used in decision making of revascularization. If PCI is not performed for lesions with MPFFR≤0.80 or FFR≤0.80, the specific reasons will be collected in electronic case report form. For lesions with MPFFR\>0.80 or FFR\>0.80, PCI will be deferred.
Locations (25)
Korea University Anam Hospital
Seoul, Select State, South Korea
Inje University Haeundae Paik Hospital
Busan, South Korea
Changwon Fatima Hospital
Changwon, South Korea
Gyeongsang National University Changwon Hospital
Changwon, South Korea
Keimyung University Dongsan Hospital
Daegu, South Korea
Kyungpook National University Hospital
Daegu, South Korea
Chonnam National University Hospital, Chonnam National University Medical School
Gwangju, South Korea
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, South Korea
CHA Bundang Medical Center
Gyeonggi-do, South Korea
Wonkwang University Hospital
Iksan, South Korea
Inje University College of Medicine, Ilsan Paik Hospital
Ilsan, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Inha University Hospital
Incheon, South Korea
International St. Mary's Hospital
Incheon, South Korea
Presbyterian Medical Center
Jeonju, South Korea
Gyeongsang National University Hospital
Jinju, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Samsung Medical Center
Seoul, South Korea
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Seoul National University Boramae Medical Center
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
Uijeongbu ST. Mary's Hospital
Uijeongbu-si, South Korea
Ulsan University Hospital
Ulsan, South Korea
Wonju Severance Christian Hospital
Wŏnju, South Korea