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

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.

Conditions

• Coronary Artery Disease
• Chronic Coronary Syndrome
• Acute Coronary Syndrome

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

• Chonnam National University Hospital

  collaborator OTHER

• Seoul National University Bundang Hospital

  collaborator OTHER

• Chung-Ang University Gwangmyeong Hospital

  collaborator OTHER

• The Catholic University of Korea

  collaborator OTHER

• Keimyung University Dongsan Medical Center

  collaborator OTHER

• Wonju Severance Christian Hospital

  collaborator OTHER

• SMG-SNU Boramae Medical Center

  collaborator OTHER

• Kangbuk Samsung Hospital, Sungkyunkwan University

  collaborator OTHER

• Korea University Guro Hospital

  collaborator OTHER

• Inje University Ilsan Paik Hospital

  collaborator OTHER

• International St. Mary's Hospital

  collaborator UNKNOWN

• Kyungpook National University Hospital

  collaborator OTHER

• Korea University Anam Hospital

  collaborator OTHER

• Ajou University School of Medicine

  collaborator OTHER

• Changwon Patima Hospital

  collaborator UNKNOWN

• Bundang CHA Hospital

  collaborator OTHER

• Ulsan University Hospital

  collaborator OTHER

• Gachon University Gil Medical Center

  collaborator OTHER

• Inje University Haeundae Paik Hospital

  collaborator OTHER

• Gyeongsang National University Changwon Hospital

  collaborator OTHER

• Wonkwang University Hospital

  collaborator OTHER

• Samsung Medical Center

  lead OTHER

Principal Investigators

• Joo Myung Lee, MD, MPH, PhD · Samsung Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-18

Primary Completion

2028-12-31

Completion

2029-12-31

Countries

• South Korea

Study Locations