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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSamsung Medical Center

About this trial

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 criteria

Qualifiers

Subject must be at least 19 years of age

Eligible for coronary angiography and/or percutaneous coronary intervention.

Chronic coronary syndrome or acute coronary syndrome (non-culprit vessels only)

Coronary artery disease in one or more native major epicardial vessels or their branches with reference vessel diameter of at least 2.5mm and with visually assessed coronary stenosis in which the physiological severity of the lesion is questionable (typically 40-90% diameter stenosis).

Disqualifiers

Patients unable to provide informed consent

Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents and drug-coated balloons

Patients with coronary artery bypass grafting

Patients who have non-cardiac co-morbid conditions with life expectancy <1 year

Trial design

Treatments tested in this trial

  • MPFFR or Invasive FFR

Treatment groups

2,100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Samsung Medical Center

Lead sponsor

Chonnam National University Hospital

Collaborator

Seoul National University Bundang Hospital

Collaborator

Chung-Ang University Gwangmyeong Hospital

Collaborator

The Catholic University of Korea

Collaborator

Keimyung University Dongsan Medical Center

Collaborator

Wonju Severance Christian Hospital

Collaborator

SMG-SNU Boramae Medical Center

Collaborator

Kangbuk Samsung Hospital, Sungkyunkwan University

Collaborator

Korea University Guro Hospital

Collaborator

Inje University Ilsan Paik Hospital

Collaborator

International St. Mary's Hospital

Collaborator

Kyungpook National University Hospital

Collaborator

Korea University Anam Hospital

Collaborator

Ajou University School of Medicine

Collaborator

Changwon Patima Hospital

Collaborator

Bundang CHA Hospital

Collaborator

Ulsan University Hospital

Collaborator

Gachon University Gil Medical Center

Collaborator

Inje University Haeundae Paik Hospital

Collaborator

Gyeongsang National University Changwon Hospital

Collaborator

Wonkwang University Hospital

Collaborator