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NCT Number: NCT06985693

Medipixel XA-Assisted PCI in Coronary Artery Disease

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.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung-Ang University Gwangmyeong Hospital, Gwangmyeong, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medipixel XA-Assisted Percutaneous Coronary Intervention

Procedure

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.

Other names: MPXA-PCI

Primary outcomes

  1. Target Vessel Failure (TVF)

    Time frame: 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 outcomes

  1. Minimal Lumen Diameter (MLD) Assessed by MPXA

    Time frame: Immediately post-procedure

    Post-PCI minimal lumen diameter as measured by Medipixel XA.

  2. Residual Stenosis (%) Assessed by MPXA

    Time frame: Immediately post-procedure

    Percentage of remaining stenosis in the treated lesion, as analyzed by MPXA.

  3. MPXA Success Rate

    Time frame: Immediately post-procedure

    Defined as residual stenosis <20% as assessed by Medipixel XA and TIMI 3 flow in the target vessel.

  4. Death

    Time frame: 12 months post-procedure

  5. Myocardial Infarction

    Time frame: 12 months post-procedure

  6. Revascularization

    Time frame: 12 months post-procedure

  7. Stent Thrombosis

    Time frame: 12 months post-procedure

  8. Incidence of Periprocedural Complications

    Time frame: Immediately post-procedure

    Rate of complications such as coronary dissection, perforation, and no-reflow phenomenon.

  9. Rate of Proper Pre-Dilation Balloon Selection

    Time frame: Immediately post-procedure

    Proportion of cases where pre-dilation balloon size was chosen according to MPXA analysis.

  10. Rate of Proper Stent Sizing Selection

    Time frame: Immediately post-procedure

    Proportion of cases where the stent size was selected according to MPXA recommendations.

  11. Frequency of Post-Dilation

    Time frame: Immediately post-procedure

    Number of cases where post-dilation was performed

  12. Rate of Proper Post-Dilation Balloon Selection

    Time frame: Immediately post-procedure

    Proportion of cases where the balloon size adhered to MPXA recommendations.

Other outcomes

  1. Types and Frequency of Additional Interventions Following Intravascular Imaging During PCI

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hwa-In Kim

CONTACT

[email protected]

+82-31-780-5858

Seung-Yul Lee

CONTACT

[email protected]

+82-31-780-5858

Sponsors and collaborators

Lead sponsor

CHA University

Other

Registry information

Official study title

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

Acronym: MAP I

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 22, 2025
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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