Medipixel XA-Assisted PCI in Coronary Artery Disease

Not Applicable

Recruiting

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

• Registration Number: NCT06985693
• Lead Sponsor: CHA University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-15
• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-22
• Last Update Posted: 2025-05-22
• Primary Completion: 2028-05
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 830

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Stent Thrombosis	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 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
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.
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 Post-Dilation Balloon Selection	Immediately post-procedure	Proportion of cases where the balloon size adhered to MPXA recommendations.

Trial Locations

Locations (6)

CHA Bundang Medical Center; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of

Chung-Ang University Gwangmyeong Hospital; 🇰🇷 Gwangmyeong, Gyeonggi, Korea, Republic of

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju, Korea, Republic of

Presbyterian Medical Center; 🇰🇷 Jeonju, Korea, Republic of

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of