RecruitingNot ApplicableNCT07329699

Artificial Intelligence-Driven Medipixel Fractional Flow Reserve Versus Invasive Fractional Flow Reserve-Guided PCI Trial (AIM-FFR Trial)

Artificial Intelligence-Driven Angiography-Based Fractional Flow Reserve Versus Invasive Fractional Flow Reserve-Guided PCI


Sponsor

Samsung Medical Center

Enrollment

2,100 participants

Start Date

Mar 18, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying MPFFR or Invasive FFR for people with acute coronary syndrome, chronic coronary syndrome, and other related conditions. The study is currently recruiting participants at 23 locations. People eligible for this study include aged 19 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTMPFFR 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(23)

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

International St. Mary's Hospital

Incheon, 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

View Full Details on ClinicalTrials.gov

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