Artificial Intelligence-Driven Medipixel Fractional Flow Reserve Versus Invasive Fractional Flow Reserve-Guided PCI Trial (AIM-FFR Trial)
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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
Primary outcome measure(s)
- Major adverse cardiac events (MACE) — 1 year after last patient enrollment
a composite of death from any causes, non-fatal myocardial infarction \[MI\], and clinically indicated unplanned revascularization
Trial sites (23)
| Facility | City | Region | Status |
|---|---|---|---|
| Korea University Anam Hospital | Seoul | Select State | Recruiting |
| Inje University Haeundae Paik Hospital | Busan | South Korea | Recruiting |
| Changwon Fatima Hospital | Changwon | South Korea | Recruiting |
| Gyeongsang National University Changwon Hospital | Changwon | South Korea | Recruiting |
| Keimyung University Dongsan Hospital | Daegu | South Korea | Recruiting |
| Kyungpook National University Hospital | Daegu | South Korea | Recruiting |
| Chonnam National University Hospital, Chonnam National University Medical School | Gwangju | South Korea | Recruiting |
| Chung-Ang University Gwangmyeong Hospital | Gwangmyeong | South Korea | Recruiting |
| CHA Bundang Medical Center | Gyeonggi-do | South Korea | Recruiting |
| Wonkwang University Hospital | Iksan | South Korea | Recruiting |
| Inje University College of Medicine, Ilsan Paik Hospital | Ilsan | South Korea | Recruiting |
| Gachon University Gil Medical Center | Incheon | South Korea | Recruiting |
| International St. Mary's Hospital | Incheon | South Korea | Recruiting |
| Gyeongsang National University Hospital | Jinju | South Korea | Recruiting |
| Seoul National University Bundang Hospital | Seongnam | South Korea | Recruiting |
| Samsung Medical Center | Seoul | South Korea | Recruiting |
| Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine | Seoul | South Korea | Recruiting |
| Korea University Guro Hospital | Seoul | South Korea | Recruiting |
| Seoul National University Boramae Medical Center | Seoul | South Korea | Recruiting |
| Ajou University Hospital | Suwon | South Korea | Recruiting |
| Uijeongbu ST. Mary's Hospital | Uijeongbu-si | South Korea | Recruiting |
| Ulsan University Hospital | Ulsan | South Korea | Recruiting |
| Wonju Severance Christian Hospital | Wŏnju | South Korea | Recruiting |
More Samsung Medical Center trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07329699 on ClinicalTrials.gov ↗ ← All trials in South Korea