Medipixel XA-Assisted PCI in Coronary Artery Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Medipixel XA-Assisted Percutaneous Coronary Intervention.
- Who it may be relevant to
- Registry conditions: Percutaneous Coronary Intervention (PCI), Coronary Arterial Disease (CAD). Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Medipixel XA-Assisted Percutaneous Coronary Intervention in Coronary Artery Disease: A Prospective Multicenter Study
Overview
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.
Interventions
- Procedure Medipixel XA-Assisted Percutaneous Coronary Intervention
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 t
Primary outcome measures
- Target Vessel Failure (TVF) [Time frame: 12 months post-procedure]
Secondary outcome measures (12)
- Minimal Lumen Diameter (MLD) Assessed by MPXA [Time frame: Immediately post-procedure]
- Residual Stenosis (%) Assessed by MPXA [Time frame: Immediately post-procedure]
- MPXA Success Rate [Time frame: Immediately post-procedure]
- Death [Time frame: 12 months post-procedure]
- Myocardial Infarction [Time frame: 12 months post-procedure]
- Revascularization [Time frame: 12 months post-procedure]
- Stent Thrombosis [Time frame: 12 months post-procedure]
- Incidence of Periprocedural Complications [Time frame: Immediately post-procedure]
- Rate of Proper Pre-Dilation Balloon Selection [Time frame: Immediately post-procedure]
- Rate of Proper Stent Sizing Selection [Time frame: Immediately post-procedure]
- Frequency of Post-Dilation [Time frame: Immediately post-procedure]
- Rate of Proper Post-Dilation Balloon Selection [Time frame: Immediately post-procedure]
Eligibility criteria
Inclusion criteria
- Silent ischemia, stable or unstable angina, or myocardial infarction
- De novo coronary lesion eligible for DES implantation
- Lesions analyzable by MPXA
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 6 centers
- Chung-Ang University Gwangmyeong Hospital — Gwangmyeong
- CHA Bundang Medical Center — Seongnam-si
- Keimyung University Dongsan Medical Center — Daegu
- Chonnam National University Hospital — Gwangju
- Presbyterian Medical Center — Jeonju
- Ulsan University Hospital — Ulsan
Publications
- 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.j PMID 39614852
- Lee 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 35861828
Identifiers
NCT: NCT06985693 · CHAMC IRB 2025-02-065-001