Medipixel XA-Assisted PCI in Coronary Artery Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorCHA University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Silent ischemia, stable or unstable angina, or myocardial infarction
De novo coronary lesion eligible for DES implantation
Lesions analyzable by MPXA
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Medipixel XA-Assisted Percutaneous Coronary Intervention
Procedure/SurgeryMedipixel 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.
Treatment groups
830 Participants
are divided into 1 treatment groupGroup A: Medipixel XA-Assisted PCI GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Target 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-procedureSecondary outcomes
1
Minimal Lumen Diameter (MLD) Assessed by MPXA
Post-PCI minimal lumen diameter as measured by Medipixel XA.
Time frame
Immediately post-procedure2
Residual Stenosis (%) Assessed by MPXA
Percentage of remaining stenosis in the treated lesion, as analyzed by MPXA.
Time frame
Immediately post-procedure3
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-procedure4
Death
Time frame
12 months post-procedureOther outcomes
1
Types and Frequency of Additional Interventions Following Intravascular Imaging During PCI
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.
Time frame
Immediately post-procedureSponsors and contacts
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Source ClinicalTrials.gov