Medipixel XA-Assisted Percutaneous Coronary Intervention in Coronary Artery Disease: A Prospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 830
- 试验地点
- 6
- 主要终点
- Target Vessel Failure (TVF)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Silent ischemia, stable or unstable angina, or myocardial infarction
- •De novo coronary lesion eligible for DES implantation
- •Lesions analyzable by MPXA
排除标准
- •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
研究组 & 干预措施
Medipixel XA-Assisted PCI Group
干预措施: Medipixel XA-Assisted Percutaneous Coronary Intervention (Procedure)
结局指标
主要结局
Target Vessel Failure (TVF)
时间窗: 12 months post-procedure
Target vessel failure (TVF) is a composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularization (TVR).
次要结局
- Rate of Proper Pre-Dilation Balloon Selection(Immediately post-procedure)
- Minimal Lumen Diameter (MLD) Assessed by MPXA(Immediately post-procedure)
- Residual Stenosis (%) Assessed by MPXA(Immediately post-procedure)
- Incidence of Periprocedural Complications(Immediately post-procedure)
- MPXA Success Rate(Immediately post-procedure)
- Death(12 months post-procedure)
- Myocardial Infarction(12 months post-procedure)
- Revascularization(12 months post-procedure)
- Stent Thrombosis(12 months post-procedure)
- Rate of Proper Stent Sizing Selection(Immediately post-procedure)
- Frequency of Post-Dilation(Immediately post-procedure)
- Rate of Proper Post-Dilation Balloon Selection(Immediately post-procedure)
研究者
Seung-Yul Lee
Associate Professor of Internal Medicine, CHA Bundang Medical Center, CHA University, South Korea
CHA University