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

April 21, 2026 updated by: Joo Myung Lee, Samsung Medical Center

Artificial Intelligence-Driven Angiography-Based Fractional Flow Reserve Versus Invasive Fractional Flow Reserve-Guided PCI

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Fractional Flow Reserve (FFR) has been established as the gold standard for determining the functional significance of coronary artery stenosis. Current guidelines have classified FFR as a Class IA recommendation for the assessment of intermediate coronary artery lesions. However, FFR remains underused in daily clinical practice, due to requirement for pressure wire use, hyperemia induction, or prolonged procedural time.

To overcome these limitations, angiography-derived computation of FFR have been widely adopted as wire-free alternatives. These technologies enable functional assessment of coronary stenosis without pressure wires, providing a less invasive and more comfortable alternative to wire-based FFR. Multiple modalities have shown reasonable diagnostic accuracy to predict FFR≤0.80. Among them, Quantitative Flow Ratio (QFR)-guided percutaneous coronary intervention (PCI) demonstrated superior clinical outcome than angiography-guided PCI. Based on these results, QFR-guided PCI is supported by class 1B recommendation from European Society of Cardiology guideline. Nevertheless, angiography-derived FFR also has limitations, primarily related to the technical and workflow demands of the process. Computation of angiography-derived FFR typically requires vessel segmentation, correspondence marking, and 3-dimensional reconstruction from angiographic images, which are time-consuming and subject to operator-dependent variability.

Indeed, recent data shows limitations of angiography-based FFR computation. Study by Ninomiya et al. evaluated five different angiography-derived FFR methods (QFR, vFFR from Pie Medical Imaging, caFFR from Rainmed Ltd, 2D-µFR, and 3D-µFR from Pulse Medical Imaging Technology). Although these angiography-derived FFR methods provided higher discrimination than angiographic stenosis severity to discriminate functionally significant stenosis defined by FFR≤0.80 or instantaneous wave-free ratio≤0.89, the AUC ranged from 0.65 to 0.75. Furthermore, recent FAVOR III Europe trial showed that QFR-guided strategy did not meet non-inferiority to FFR-guided strategy in terms of a composite of death, myocardial infarction, and unplanned revascularization at 12 months. These results support invasive FFR-guided strategy is gold standard method.

Recent advances in Artificial Intelligence (AI) have led to development of automated tools for cardiovascular diagnostics, improving both accuracy and workflow efficiency. The AI-driven angiography-based FFR (Medipixel FFR [MPFFR]) has been developed utilizing AI-based fully automated quantitative coronary angiography (AI-QCA). MPFFR utilizes automated frame selection, AI-based contouring, and real-time modeling, allowing for rapid and accurate physiological assessment without manual segmentation. In previous validation study conducted in Korea (599 vessels from 452 patients who underwent clinically indicated FFR measurement from 5 university hospitals in Korea), Mean analysis time of MPFFR was 12.5±1.7 seconds and manual correction was needed in 32 vessels (5.3%). MPFFR showed similar diagnostic performance with QFR (correlation with FFR; MPFFR vs. QFR: R=0.885 vs. R=0.860, P for comparison=0.011; area under curve to predict FFR≤0.80; 0.949 vs. 0.953, P for comparison=0.631). At a median follow-up of 2 years (interquartile range, 1.6 to 2.6 years), patients with MPFFR≤0.80 had higher risk of target vessel failure than those with MPFFR>0.80 (4.5% vs. 0.8%; adjusted HR, 5.94; 95% CI, 1.27-27.91; P=0.024). C-index to predict target vessel failure was comparable between MPFFR and QFR (0.770 vs. 0.753, P for comparison=0.469).

However, whether MPFFR-guided PCI can be used in daily practice still needs to be validated by randomized controlled trial using invasive FFR-guided PCI as reference standard. On this background, the current trial aims to compare clinical outcomes between MPFFR-guided PCI and invasive FFR-guided PCI in patients with coronary artery disease.

Study Type

Interventional

Enrollment (Estimated)

2100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • South Korea
      • Busan, South Korea
        • Recruiting
        • Inje University Haeundae Paik Hospital
        • Principal Investigator:
          • Dong Ki Kim, MD, PhD
        • Contact:
      • Changwon, South Korea
        • Recruiting
        • Gyeongsang National University Changwon Hospital
        • Contact:
        • Principal Investigator:
          • Jong Hwa Ahn, MD, PhD
      • Changwon, South Korea
        • Recruiting
        • Changwon fatima hospital
        • Contact:
        • Principal Investigator:
          • Jae Kwang Lee, MD, PhD
      • Daegu, South Korea
        • Recruiting
        • Keimyung University Dongsan Hospital
        • Contact:
        • Principal Investigator:
          • Hyuck-Jun Yoon, MD, PhD
      • Daegu, South Korea
        • Recruiting
        • Kyungpook National University Hospital
        • Contact:
        • Principal Investigator:
          • Namkyun Kim, MD, PhD
        • Sub-Investigator:
          • Jang Hoon Lee, MD, PhD
      • Gwangju, South Korea
        • Recruiting
        • Chonnam National University Hospital, Chonnam National University Medical School
        • Contact:
        • Sub-Investigator:
          • Seung Hun Lee, MD, PhD
        • Contact:
        • Principal Investigator:
          • Young Joon Hong, MD, PhD
        • Sub-Investigator:
          • Joon Ho Ahn, MD, PhD
      • Gwangmyeong, South Korea
        • Recruiting
        • Chung-Ang University Gwangmyeong Hospital
        • Contact:
        • Principal Investigator:
          • Sang Yeub Lee, MD, PhD
        • Sub-Investigator:
          • Jun Hwan Cho, MD, PhD
        • Sub-Investigator:
          • Jinhwan Jo, MD, PhD
      • Gyeonggi-do, South Korea
        • Recruiting
        • CHA Bundang Medical Center
        • Contact:
        • Principal Investigator:
          • Seung Yul Lee, MD, PhD
      • Iksan, South Korea
        • Recruiting
        • Wonkwang University Hospital
        • Principal Investigator:
          • Kyeong Ho Yun, MD, PhD
        • Contact:
      • Ilsan, South Korea
        • Recruiting
        • Inje University College of Medicine, Ilsan Paik Hospital
        • Contact:
        • Principal Investigator:
          • Sung Woo Cho, MD, PhD
        • Sub-Investigator:
          • Sung-Eun Kim, MD, PhD
      • Incheon, South Korea
        • Recruiting
        • Gachon University Gil Medical Center
        • Contact:
        • Principal Investigator:
          • Albert Youngwoo Jang, MD, PhD
        • Sub-Investigator:
          • Joon-Pyo Lee, MD, PhD
      • Incheon, South Korea
        • Recruiting
        • International St. Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Hyung Bok Park, MD, PhD
      • Jinju, South Korea
        • Recruiting
        • Gyeongsang National University Hospital
        • Sub-Investigator:
          • Min Gyu Kang, MD, PhD
        • Contact:
        • Principal Investigator:
          • Jin Sin Koh, MD, PhD
        • Sub-Investigator:
          • Hangyul Kim, MD, PhD
      • Seongnam, South Korea
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Principal Investigator:
          • Ki-Hyun Jeon, MD
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Joo Myung Lee, MD, MPH, PhD
        • Contact:
        • Sub-Investigator:
          • Taek Kyu Park, MD, PhD
        • Sub-Investigator:
          • Jeong Hoon Yang, MD, PhD
        • Sub-Investigator:
          • Young Bin Song, MD, PhD
        • Sub-Investigator:
          • Ki-Hong Choi, MD, PhD
        • Sub-Investigator:
          • Joo Yong Hahn, MD, PhD
        • Sub-Investigator:
          • Sang Yoon Lee, MD, PhD
      • Seoul, South Korea
        • Recruiting
        • Korea University Guro Hospital
        • Contact:
        • Principal Investigator:
          • Dong-Oh Kang, MD, PhD
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Boramae Medical Center
        • Contact:
        • Principal Investigator:
          • Hyun Sung Joh, MD, PhD
      • Seoul, South Korea
        • Recruiting
        • Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
        • Contact:
        • Sub-Investigator:
          • Seung-Jae Lee, MD, PhD
        • Sub-Investigator:
          • Woochan Kwon, MD, PhD
        • Contact:
      • Suwon, South Korea
        • Recruiting
        • Ajou University Hospital
        • Contact:
        • Principal Investigator:
          • Hong-Seok Lim, MD,PhD
      • Uijeongbu-si, South Korea
        • Recruiting
        • Uijeongbu St. Mary's Hospital
        • Contact:
        • Principal Investigator:
          • Chan Joon Kim, MD, PhD
        • Sub-Investigator:
          • Seong Hyeon Bu, MD, PhD
      • Ulsan, South Korea
        • Recruiting
        • Ulsan University Hospital
        • Contact:
        • Principal Investigator:
          • Eun-Seok Shin, MD, PhD
      • Wŏnju, South Korea
        • Recruiting
        • Wonju Severance Christian Hospital
        • Contact:
        • Principal Investigator:
          • Sung Gyun Ahn, MD, PhD
        • Sub-Investigator:
          • Jung-Hee Lee, MD, PhD
    • Select State
      • Seoul, Select State, South Korea
        • Recruiting
        • Korea University Anam Hospital
        • Contact:
        • Principal Investigator:
          • Jung-Joon Cha, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MPFFR-guided PCI group

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
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.
Active Comparator: Invasive FFR-guided PCI group

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac events (MACE)
Time Frame: 1 year after last patient enrollment
a composite of death from any causes, non-fatal myocardial infarction [MI], and clinically indicated unplanned revascularization
1 year after last patient enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death
Time Frame: 1 year after last patient enrollment
All-cause death (defined by Academic Research Consortium [ARC] II definition)
1 year after last patient enrollment
Cardiovascular death
Time Frame: 1 year after last patient enrollment
Cardiovascular death (defined by Academic Research Consortium [ARC] II definition)
1 year after last patient enrollment
Non-fatal myocardial infarction (MI)
Time Frame: 1 year after last patient enrollment
Non-fatal MI (according to the Fourth universal definition of MI)
1 year after last patient enrollment
Target vessel-related MI
Time Frame: 1 year after last patient enrollment
Target vessel-related MI (Target vessel denotes vessels with initially interrogated by MPFFR or invasive FFR)
1 year after last patient enrollment
Non-target vessel-related MI
Time Frame: 1 year after last patient enrollment
Non-target vessel-related MI (Target vessel denotes vessels with initially interrogated by MPFFR or invasive FFR)
1 year after last patient enrollment
Clinically indicated unplanned revascularization
Time Frame: 1 year after last patient enrollment
Clinically indicated unplanned revascularization (defined by Academic Research Consortium [ARC] II definition)
1 year after last patient enrollment
Clinically indicated target vessel revascularization
Time Frame: 1 year after last patient enrollment
Clinically indicated target vessel revascularization (Target vessel denotes vessels with initially interrogated by MPFFR or invasive FFR)
1 year after last patient enrollment
Clinically indicated non-target vessel repeat revascularization
Time Frame: 1 year after last patient enrollment
Clinically indicated non-target vessel repeat revascularization (Target vessel denotes vessels with initially interrogated by MPFFR or invasive FFR)
1 year after last patient enrollment
Vessel or Stent thrombosis
Time Frame: 1 year after last patient enrollment
Vessel or Stent thrombosis (definite thrombosis defined by Academic Research Consortium [ARC] II definition)
1 year after last patient enrollment
Cardiovascular death or target vessel-related MI
Time Frame: 1 year after last patient enrollment
A composite of Cardiovascular death or target vessel-related MI
1 year after last patient enrollment
Target vessel failure
Time Frame: 1 year after last patient enrollment
Target vessel failure (TVF, a composite of cardiovascular death, target vessel-related MI, and clinically indicated target vessel revascularization)
1 year after last patient enrollment
Bleeding according to BARC definition
Time Frame: 1 year after last patient enrollment
Bleeding according to BARC definition
1 year after last patient enrollment
Cerebrovascular accident (CVA)
Time Frame: 1 year after last patient enrollment
Cerebrovascular accident (CVA) including ischemic stroke, hemorrhagic stroke, or transient ischemic attack (TIA)
1 year after last patient enrollment
Contrast volume (including both diagnostic angiography and PCI)
Time Frame: immediately after the intervention/procedure
Contrast volume (including both diagnostic angiography and PCI)
immediately after the intervention/procedure
Procedure time of MPFFR or invasive FFR measurement
Time Frame: immediately after the intervention/procedure
Procedure time of MPFFR or invasive FFR measurement
immediately after the intervention/procedure
Procedure time including the decision-making time for PCI following coronary angiography
Time Frame: immediately after the intervention/procedure
Procedure time including the decision-making time for PCI following coronary angiography
immediately after the intervention/procedure
Number of lesions interrogated
Time Frame: immediately after the intervention/procedure
Number of lesions interrogated by MPFFR or invasive FFR
immediately after the intervention/procedure
Number of used stents or drug-coated balloons
Time Frame: immediately after the intervention/procedure
Number of used stents or drug-coated balloons
immediately after the intervention/procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Collaborators

Chonnam National University Hospital
Ulsan University Hospital
Korea University Anam Hospital
Seoul National University Bundang Hospital
Korea University Guro Hospital
Gachon University Gil Medical Center
Ajou University School of Medicine
Kyungpook National University Hospital
SMG-SNU Boramae Medical Center
The Catholic University of Korea
Bundang CHA Hospital
Keimyung University Dongsan Medical Center
Wonju Severance Christian Hospital
Wonkwang University Hospital
Inje University Ilsan Paik Hospital
International St. Mary's Hospital
Chung-Ang University Gwangmyeong Hospital
Gyeongsang National University Changwon Hospital
Inje University Haeundae Paik Hospital
Kangbuk Samsung Hospital, Sungkyunkwan University
Changwon Patima Hospital

Investigators

  • Principal Investigator: Joo Myung Lee, MD, MPH, PhD, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

December 23, 2025

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC19810222

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Reseanable request will be reviwed by the Executive Committee.

IPD Sharing Time Frame

After publication of primary report and prespecified subgroup analysis.

IPD Sharing Access Criteria

Reseanable request will be reviwed by the Executive Committee.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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