RecruitingNot ApplicableNCT06985693

Medipixel XA-Assisted PCI in Coronary Artery Disease

Medipixel XA-Assisted Percutaneous Coronary Intervention in Coronary Artery Disease: A Prospective Multicenter Study

Sponsor

CHA University

Enrollment

830 participants

Start Date

May 15, 2025

Study Type

INTERVENTIONAL

Conditions

Coronary Arterial Disease (CAD)Percutaneous Coronary Intervention (PCI)

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.

Eligibility

Min Age: 19 Years

Inclusion Criteria3

Silent ischemia, stable or unstable angina, or myocardial infarction
De novo coronary lesion eligible for DES implantation
Lesions analyzable by MPXA

Exclusion Criteria8

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

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Interventions

PROCEDUREMedipixel 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 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.