Acute Coronary Syndrome Clinical Trials

Find Acute Coronary Syndrome Clinical Trials Near You

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

Status: Recruiting
Location: See all (23) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Republic of Korea
Inje University Haeundae Paik Hospital
RECRUITING
Busan
Changwon Fatima Hospital
RECRUITING
Changwon
Gyeongsang National University Changwon Hospital
RECRUITING
Changwon
Keimyung University Dongsan Hospital
RECRUITING
Daegu
Kyungpook National University Hospital
RECRUITING
Daegu
Chonnam National University Hospital, Chonnam National University Medical School
RECRUITING
Gwangju
Chung-Ang University Gwangmyeong Hospital
RECRUITING
Gwangmyeong
CHA Bundang Medical Center
RECRUITING
Gyeonggi-do
Wonkwang University Hospital
RECRUITING
Iksan
Inje University College of Medicine, Ilsan Paik Hospital
RECRUITING
Ilsan
Gachon University Gil Medical Center
RECRUITING
Incheon
International St. Mary's Hospital
RECRUITING
Incheon
Gyeongsang National University Hospital
RECRUITING
Jinju
Seoul National University Bundang Hospital
RECRUITING
Seongnam
Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine
RECRUITING
Seoul
Korea University Anam Hospital
RECRUITING
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Boramae Medical Center
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
Uijeongbu ST. Mary's Hospital
RECRUITING
Uijeongbu-si
Ulsan University Hospital
RECRUITING
Ulsan
Wonju Severance Christian Hospital
RECRUITING
Wŏnju
Contact Information
Primary
Joo Myung Lee, MD, MPH, PhD
drone80@hanmail.net
0234102575
Backup
Seung Hun Lee, MD, PhD
lsh8602@naver.com
821064137449
Time Frame
Start Date: 2026-03-18
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 2100
Treatments
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.
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.
Sponsors
Collaborators: Seoul National University Bundang Hospital, The Catholic University of Korea, Wonkwang University Hospital, Chonnam National University Hospital, Changwon Patima Hospital, Kangbuk Samsung Hospital, Sungkyunkwan University, Inje University Haeundae Paik Hospital, Korea University Guro Hospital, Ajou University School of Medicine, Bundang CHA Hospital, Ulsan University Hospital, Keimyung University Dongsan Medical Center, Chung-Ang University Gwangmyeong Hospital, SMG-SNU Boramae Medical Center, Gachon University Gil Medical Center, International St. Mary's Hospital, Korea University Anam Hospital, Wonju Severance Christian Hospital, Gyeongsang National University Changwon Hospital, Inje University Ilsan Paik Hospital, Kyungpook National University Hospital
Leads: Samsung Medical Center

This content was sourced from clinicaltrials.gov