Medipixel XA-Assisted PCI in Coronary Artery Disease (MAP I)

CHA University

Status: Enrolling

Conditions: Coronary Arterial Disease (CAD); Percutaneous Coronary Intervention (PCI)

Treatments: Procedure: Medipixel XA-Assisted Percutaneous Coronary Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06985693

CHAMC IRB 2025-02-065-001

Details and patient eligibility

About

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.

Enrollment: 830 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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830 participants in 1 patient group

Medipixel XA-Assisted PCI Group

Experimental group

Treatment:

Procedure: Medipixel XA-Assisted Percutaneous Coronary Intervention