Medipixel XA-Assisted PCI in Coronary Artery Disease
MAP I
Medipixel XA-Assisted Percutaneous Coronary Intervention in Coronary Artery Disease: A Prospective Multicenter Study
1 other identifier
interventional
830
1 country
6
Brief Summary
This prospective, multicenter, single-arm, interventional study evaluates the effectiveness and safety of Medipixel XA-Assisted Percutaneous Coronary Intervention (MPXA-PCI) in patients with coronary artery disease (CAD). The study aims to assess procedural success rates and clinical outcomes associated with the novel MPXA-assisted PCI strategy in a real-world clinical setting. A total of 830 patients with de novo coronary lesions eligible for drug-eluting stent (DES) implantation will be enrolled. All participants will undergo MPXA-assisted lesion assessment to optimize balloon and stent selection. The primary outcome is target vessel failure (TVF) at 12 months, defined as a composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularization. Secondary outcomes include procedural success, angiographic results, and periprocedural complications. This study will provide evidence regarding the clinical applicability and safety of artificial intelligence-assisted quantitative coronary analysis (AI-QCA) technology for optimizing PCI procedures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2025
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2025
CompletedStudy Start
First participant enrolled
May 15, 2025
CompletedFirst Posted
Study publicly available on registry
May 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
May 22, 2025
May 1, 2025
3 years
May 15, 2025
May 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Target Vessel Failure (TVF)
Target vessel failure (TVF) is a composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularization (TVR).
12 months post-procedure
Secondary Outcomes (12)
Minimal Lumen Diameter (MLD) Assessed by MPXA
Immediately post-procedure
Residual Stenosis (%) Assessed by MPXA
Immediately post-procedure
MPXA Success Rate
Immediately post-procedure
Death
12 months post-procedure
Myocardial Infarction
12 months post-procedure
- +7 more secondary outcomes
Other Outcomes (1)
Types and Frequency of Additional Interventions Following Intravascular Imaging During PCI
Immediately post-procedure
Study Arms (1)
Medipixel XA-Assisted PCI Group
EXPERIMENTALInterventions
Medipixel XA-Assisted Percutaneous Coronary Intervention (MPXA-PCI) is an AI-assisted coronary intervention procedure utilizing Medipixel XA (MPXA), an artificial intelligence-based quantitative coronary analysis (AI-QCA) software. MPXA analyzes angiographic images in real-time to assist in lesion assessment, optimal balloon and stent selection, and procedural decision-making during percutaneous coronary intervention (PCI). In this study, all participants will undergo MPXA-assisted PCI, where the software provides automated vessel segmentation, diameter measurement, and lesion quantification to optimize procedural outcomes. Operators will follow a predefined protocol incorporating MPXA measurements for balloon sizing, stent selection, and post-dilation strategies. The study evaluates the safety, feasibility, and clinical impact of MPXA-assisted PCI in real-world coronary artery disease patients.
Eligibility Criteria
You may qualify if:
- Silent ischemia, stable or unstable angina, or myocardial infarction
- De novo coronary lesion eligible for DES implantation
- Lesions analyzable by MPXA
You may not qualify if:
- Comorbidity with a life expectancy \<12 months
- Intolerant of antithrombotic therapy
- Significant anemia, thrombocytopenia, or leucopenia
- History of major hemorrhage (intracranial, gastrointestinal, and so on)
- Chronic total occlusion lesion
- Left main lesion
- Severe calcification needing rotational atherectomy
- Lesions not analyzable by MPXA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHA Universitylead
Study Sites (6)
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, Gyeonggi-do, 14351, South Korea
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, 13496, South Korea
Keimyung University Dongsan Medical Center
Daegu, 42601, South Korea
Chonnam National University Hospital
Gwangju, 61469, South Korea
Presbyterian Medical Center
Jeonju, 54987, South Korea
Ulsan University Hospital
Ulsan, 44033, South Korea
Related Publications (2)
Kim Y, Yoon HJ, Suh J, Kang SH, Lim YH, Jang DH, Park JH, Shin ES, Bae JW, Lee JH, Oh JH, Kang DY, Kweon J, Jo MW, Yun SC, Park DW, Kim YH, Park SJ, Park H, Ahn JM; FLASH Trial Investigators. Artificial Intelligence-Based Fully Automated Quantitative Coronary Angiography vs Optical Coherence Tomography-Guided PCI: The FLASH Trial. JACC Cardiovasc Interv. 2025 Jan 27;18(2):187-197. doi: 10.1016/j.jcin.2024.10.025. Epub 2024 Oct 30.
PMID: 39614852BACKGROUNDLee SY, Zhang JJ, Mintz GS, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Kan J, Pan T, Gao X, Ge Z, Chen SL, Hong MK. Procedural Characteristics of Intravascular Ultrasound-Guided Percutaneous Coronary Intervention and Their Clinical Implications. J Am Heart Assoc. 2022 Jul 19;11(14):e025258. doi: 10.1161/JAHA.122.025258. Epub 2022 Jul 15.
PMID: 35861828BACKGROUND
Related Links
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Internal Medicine, CHA Bundang Medical Center, CHA University, South Korea
Study Record Dates
First Submitted
May 15, 2025
First Posted
May 22, 2025
Study Start
May 15, 2025
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
May 22, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share