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
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