Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI)
Conditions
Keywords
Artificial Intelligence, Quantitative Coronary Analysis, Medipixel, MPXA
Brief 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.
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.
Sponsors
CHA University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Target Vessel Failure (TVF) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minimal Lumen Diameter (MLD) Assessed by MPXA | Immediately post-procedure | Post-PCI minimal lumen diameter as measured by Medipixel XA. |
| Residual Stenosis (%) Assessed by MPXA | Immediately post-procedure | Percentage of remaining stenosis in the treated lesion, as analyzed by MPXA. |
| MPXA Success Rate | Immediately post-procedure | Defined as residual stenosis \<20% as assessed by Medipixel XA and TIMI 3 flow in the target vessel. |
| Death | 12 months post-procedure | — |
| Myocardial Infarction | 12 months post-procedure | — |
| Revascularization | 12 months post-procedure | — |
| Incidence of Periprocedural Complications | Immediately post-procedure | Rate of complications such as coronary dissection, perforation, and no-reflow phenomenon. |
| Rate of Proper Pre-Dilation Balloon Selection | Immediately post-procedure | Proportion of cases where pre-dilation balloon size was chosen according to MPXA analysis. |
| Rate of Proper Stent Sizing Selection | Immediately post-procedure | Proportion of cases where the stent size was selected according to MPXA recommendations. |
| Frequency of Post-Dilation | Immediately post-procedure | Number of cases where post-dilation was performed |
| Rate of Proper Post-Dilation Balloon Selection | Immediately post-procedure | Proportion of cases where the balloon size adhered to MPXA recommendations. |
| Stent Thrombosis | 12 months post-procedure | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Types and Frequency of Additional Interventions Following Intravascular Imaging During PCI | Immediately post-procedure | This outcome measures the types and frequency of additional interventions performed after intravascular imaging during PCI. Additional interventions may include additional pre-dilation, rotational atherectomy, additional device implantation, additional post-dilation, and other procedures. |
Countries
South Korea
Contacts
Primary ContactHwa-In Kim
Backup ContactSeung-Yul Lee
Outcome results
None listed