NCT06985693Recruiting
Medipixel XA-Assisted PCI in Coronary Artery Disease
Medipixel XA-Assisted Percutaneous Coronary Intervention in Coronary Artery Disease: A Prospective Multicenter Study
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 830 (estimated)
- First submitted
- 15 May 2025
- Start date
- 15 May 2025
- Primary completion date
- 31 May 2028
- Lead sponsor
- CHA University
- Diseases
- Coronary artery disease
- NCT number
- NCT06985693
What you commit to
- Study type: Interventional
- Planned participants: 830
- From 15 May 2025 to the primary completion date, 31 May 2028
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Intolerant of antithrombotic therapy
Other illness
- History of major hemorrhage (intracranial, gastrointestinal, and so on)
Other
- Comorbidity with a life expectancy \<12 months
- Significant anemia, thrombocytopenia, or leucopenia
- Chronic total occlusion lesion
- Left main lesion
- Severe calcification needing rotational atherectomy
- Lesions not analyzable by MPXA
Who the study is looking for
- Silent ischemia, stable or unstable angina, or myocardial infarction
- De novo coronary lesion eligible for DES implantation
- Lesions analyzable by MPXA
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Keimyung University - Dongsan Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Recruiting |
| Chonnam National University Hospital Coordinator of this site? Confirm its status | Gwangju | South Korea | Recruiting |
| Chung-Ang University Gwangmyeong Hospital Coordinator of this site? Confirm its status | Gwangmyeong | South Korea | Recruiting |
| Presbyterian Medical Center Coordinator of this site? Confirm its status | Jeonju | South Korea | Recruiting |
| CHA Bundang Medical Center Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Recruiting |
| Ulsan University Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.