Medipixel XA-Assisted PCI in Coronary Artery Disease

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

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

Conditions3

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