AI-driven Medipixel fractional flow reserve to guide PCI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

AIM-FFR is a prospective, multicenter, open-label, randomized non-inferiority trial comparing MPFFR-guided percutaneous coronary intervention with invasive pressure-wire FFR-guided PCI. Adults with chronic coronary syndrome or acute coronary syndrome (non-culprit vessels) and visually intermediate coronary stenoses eligible for angiography/PCI will be randomized to guidance by the AI angiography-derived MPFFR or by invasive FFR. MPFFR is a wire-free, AI-enabled computation of fractional flow reserve from routine angiograms designed to reduce the need for pressure wires, hyperemia, and prolonged procedure time. The trial will compare decision-making and patient outcomes between the two guidance strategies across several tertiary centers in South Korea.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subject must be at least 19 years of age
2. Eligible for coronary angiography and/or percutaneous coronary intervention.
3. Chronic coronary syndrome or acute coronary syndrome (non-culprit vessels only)
4. 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).
5. Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.

Exclusion Criteria:

1. Patients unable to provide informed consent
2. Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents and drug-coated balloons
3. Patients with coronary artery bypass grafting
4. Patients who have non-cardiac co-morbid conditions with life expectancy \<1 year
5. Patients with cardiogenic shock or cardiac arrest
6. Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%)
7. Patients with severe valvular heart disease requiring open heart surgery
8. Pregnant or lactating women
9. Angiographic exclusion criteria

   * Culprit vessel of patients with ST-elevation myocardial infarction (target lesions in non-culprit vessel can be enrolled)
   * Chronic total occlusion (target lesions in vessels without chronic total occlusion can be enrolled)
   * Ostial stenosis in left man coronary artery or right coronary artery
   * Severe tortuosity of any target vessel
   * Severe overlap in the stenosed segment
   * Poor image quality precluding identification of vessel contours

Where it's running

• Korea University Anam Hospital
  Seoul, Select State, South Korea Recruiting
• Inje University Haeundae Paik Hospital
  Busan, South Korea Recruiting
• Changwon Fatima Hospital
  Changwon, South Korea Recruiting
• Gyeongsang National University Changwon Hospital
  Changwon, South Korea Recruiting
• Keimyung University Dongsan Hospital
  Daegu, South Korea Recruiting
• Kyungpook National University Hospital
  Daegu, South Korea Recruiting

Study contacts

• Principal investigator: Joo Myung Lee, MD, MPH, PhD — Samsung Medical Center
• Study coordinator: Joo Myung Lee, MD, MPH, PhD
• Email: drone80@hanmail.net
• Phone: 0234102575

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.