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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
830
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.
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, Gyeonggi-do, South Korea
RECRUITINGCHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
RECRUITINGKeimyung University Dongsan Medical Center
Daegu, South Korea
RECRUITINGChonnam National University Hospital
Gwangju, South Korea
RECRUITINGPresbyterian Medical Center
Jeonju, South Korea
RECRUITINGUlsan University Hospital
Ulsan, South Korea
RECRUITINGTarget 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).
Time frame: 12 months post-procedure
Minimal Lumen Diameter (MLD) Assessed by MPXA
Post-PCI minimal lumen diameter as measured by Medipixel XA.
Time frame: Immediately post-procedure
Residual Stenosis (%) Assessed by MPXA
Percentage of remaining stenosis in the treated lesion, as analyzed by MPXA.
Time frame: Immediately post-procedure
MPXA Success Rate
Defined as residual stenosis \<20% as assessed by Medipixel XA and TIMI 3 flow in the target vessel.
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
Rate of complications such as coronary dissection, perforation, and no-reflow phenomenon.
Time frame: Immediately post-procedure
Rate of Proper Pre-Dilation Balloon Selection
Proportion of cases where pre-dilation balloon size was chosen according to MPXA analysis.
Time frame: Immediately post-procedure
Rate of Proper Stent Sizing Selection
Proportion of cases where the stent size was selected according to MPXA recommendations.
Time frame: Immediately post-procedure
Frequency of Post-Dilation
Number of cases where post-dilation was performed
Time frame: Immediately post-procedure
Rate of Proper Post-Dilation Balloon Selection
Proportion of cases where the balloon size adhered to MPXA recommendations.
Time frame: Immediately post-procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.