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

NCT07329699 | Recruiting DMC

• 1 other identifier: SMC19810222
• Study Type: interventional
• Target: 2,100
• Locations: 1 country
• Sites: 23

Brief 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

Keywords

Coronary artery stenosis; Fractional flow reserve; Prognosis

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac events (MACE)

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

  1 year after last patient enrollment

Secondary Outcomes (18)

• All-cause death

  1 year after last patient enrollment

• Cardiovascular death

  1 year after last patient enrollment

• Non-fatal myocardial infarction (MI)

  1 year after last patient enrollment

• Target vessel-related MI

  1 year after last patient enrollment

• Non-target vessel-related MI

  1 year after last patient enrollment

Study Arms (2)

MPFFR-guided PCI group

EXPERIMENTAL

In patients randomized to artificial intelligence-driven angiography-based fractional flow reserve (MPFFR)-guided PCI group, MPFFR analysis will be performed using MPFFR-1000 version 2.1.0 (Medipixel Inc., Seoul, Korea). Manual correction can be applied when necessary, however, it will be strongly discouraged by the study protocols. Treatment decisions will be made based on site-measured MPFFR value. Functionally significant stenosis will be defined as MPFFR≤0.80. For lesions with MPFFR≤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, the specific reasons will be collected in electronic case report form. For lesions with MPFFR\>0.80, PCI will be deferred.

Diagnostic Test: MPFFR or Invasive FFR

Invasive FFR-guided PCI group

ACTIVE COMPARATOR

All invasive FFR measurements will be performed after diagnostic coronary angiography according to a standardized protocol as previously described. A pressure-temperature sensor guide wire (Abbott Vascular, Santa Clara, CA, USA) is positioned at the distal segment of the target lesion. To induce maximal hyperemia state, intravenous infusion of adenosine (140μg/kg/min through a peripheral vein) or intracoronary injection of nicorandil (2mg) will be used. In the presence of drift greater than 0.03 FFR unit, pressure wire will be re-equalized and FFR will be measured again. Functionally significant stenosis will be defined as FFR≤0.80. For lesions with FFR≤0.80, PCI will be recommended under current guidelines, however, final decision regarding PCI will be at the discretion of operators. If PCI is not performed for lesions with FFR≤0.80, the specific reasons will be collected in electronic case report form. For lesions with FFR\>0.80, PCI will be deferred.

Diagnostic Test: MPFFR or Invasive FFR

Interventions

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.

Invasive FFR-guided PCI group; MPFFR-guided PCI group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily.

You may not qualify if:

• 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
• Patients with cardiogenic shock or cardiac arrest
• Patients with severe left ventricular systolic dysfunction (ejection fraction \<30%)
• Patients with severe valvular heart disease requiring open heart surgery
• Pregnant or lactating women
• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• 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

Study Sites (23)

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

Chonnam National University Hospital, Chonnam National University Medical School

Gwangju, South Korea

RECRUITING

Chung-Ang University Gwangmyeong Hospital

Gwangmyeong, South Korea

RECRUITING

CHA Bundang Medical Center

Gyeonggi-do, South Korea

RECRUITING

Wonkwang University Hospital

Iksan, South Korea

RECRUITING

Inje University College of Medicine, Ilsan Paik Hospital

Ilsan, South Korea

RECRUITING

Gachon University Gil Medical Center

Incheon, South Korea

RECRUITING

International St. Mary's Hospital

Incheon, South Korea

RECRUITING

Gyeongsang National University Hospital

Jinju, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine

Seoul, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

Seoul National University Boramae Medical Center

Seoul, South Korea

RECRUITING

Ajou University Hospital

Suwon, South Korea

RECRUITING

Uijeongbu ST. Mary's Hospital

Uijeongbu-si, South Korea

RECRUITING

Ulsan University Hospital

Ulsan, South Korea

RECRUITING

Wonju Severance Christian Hospital

Wŏnju, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Joo Myung Lee, MD, MPH, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joo Myung Lee, MD, MPH, PhD

CONTACT

0234102575; drone80@hanmail.net

Seung Hun Lee, MD, PhD

CONTACT

821064137449; lsh8602@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will be blinded to the assigned groups. Clinical events will be independently adjudicated by independent Clinical Events Adjudication Committee.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A prospective, multi-center, open-label, randomized controlled, non-inferiority trial.

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 9, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After publication of primary report and prespecified subgroup analysis.
• Access Criteria: Reseanable request will be reviwed by the Executive Committee.

Locations

KR (23)