Actively Recruiting
Medipixel XA-Assisted PCI in Coronary Artery Disease
Led by CHA University · Updated on 2025-05-22
830
Participants Needed
6
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Medipixel XA-Assisted PCI in Coronary Artery Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Silent ischemia, stable or unstable angina, or myocardial infarction
- De novo coronary lesion eligible for drug-eluting stent implantation
- Lesions analyzable by Medipixel XA-Assisted PCI software
You will not qualify if you...
- Life expectancy less than 12 months due to other serious illnesses
- Intolerance to antithrombotic therapy
- Significant anemia, low platelet count, or low white blood cell count
- History of major bleeding such as intracranial or gastrointestinal hemorrhage
- Chronic total occlusion lesion
- Left main coronary artery lesion
- Severe artery calcification requiring rotational atherectomy
- Lesions that cannot be analyzed by Medipixel XA-Assisted PCI software
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, Gyeonggi-do, South Korea, 14351
Actively Recruiting
2
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea, 13496
Actively Recruiting
3
Keimyung University Dongsan Medical Center
Daegu, South Korea, 42601
Actively Recruiting
4
Chonnam National University Hospital
Gwangju, South Korea, 61469
Actively Recruiting
5
Presbyterian Medical Center
Jeonju, South Korea, 54987
Actively Recruiting
6
Ulsan University Hospital
Ulsan, South Korea, 44033
Actively Recruiting
Research Team
H
Hwa-In Kim
CONTACT
S
Seung-Yul Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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