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

ConditionsCoronary Artery Disease Chronic Coronary Syndrome Acute Coronary Syndrome

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

MPFFR or Invasive FFR
Diagnostic test
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.

Treatment groups

2,100 Participants

are divided into 2 treatment groups

Group A: MPFFR-guided PCI groupExperimental treatment 1 intervention

Group B: Invasive FFR-guided PCI groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Major adverse cardiac events (MACE)

a composite of death from any causes, non-fatal myocardial infarction \[MI\], and clinically indicated unplanned revascularization

Time frame