Using Medipixel XA technology for heart artery procedures
Medipixel XA-Assisted Percutaneous Coronary Intervention in Coronary Artery Disease: A Prospective Multicenter Study
This study is testing a new technology called Medipixel XA to see if it can make heart artery procedures safer and more effective for people with coronary artery disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 830 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | CHA University Academic / other |
| Locations | 6 sites (Gwangmyeong, Gyeonggi-do and 5 other locations) |
| Trial ID | NCT06985693 on ClinicalTrials.gov |
What this trial studies
This interventional study evaluates the effectiveness and safety of Medipixel XA-Assisted Percutaneous Coronary Intervention (MPXA-PCI) in patients with coronary artery disease. It aims to enroll 830 patients with de novo coronary lesions eligible for drug-eluting stent implantation, assessing procedural success rates and clinical outcomes in a real-world setting. Participants will undergo MPXA-assisted lesion assessment to optimize treatment selection, with primary outcomes focusing on target vessel failure at 12 months. Secondary outcomes include procedural success, angiographic results, and complications.
Who should consider this trial
Good fit: Ideal candidates include patients with silent ischemia, stable or unstable angina, or myocardial infarction who have de novo coronary lesions suitable for drug-eluting stent implantation.
Not a fit: Patients with significant comorbidities, intolerances to antithrombotic therapy, or specific lesion characteristics that are not analyzable by MPXA may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the safety and effectiveness of heart artery procedures for patients with coronary artery disease.
How similar studies have performed: Other studies utilizing advanced imaging and AI-assisted techniques in PCI have shown promising results, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Gwangmyeong, Gyeonggi-do and 5 other locations
- Chung-Ang University Gwangmyeong Hospital — Gwangmyeong, Gyeonggi-do, South Korea (Recruiting)
- CHA Bundang Medical Center — Seongnam-si, Gyeonggi-do, South Korea (Recruiting)
- Keimyung University Dongsan Medical Center — Daegu, South Korea (Recruiting)
- Chonnam National University Hospital — Gwangju, South Korea (Recruiting)
- Presbyterian Medical Center — Jeonju, South Korea (Recruiting)
- Ulsan University Hospital — Ulsan, South Korea (Recruiting)
Study contacts
- Study coordinator: Hwa-In Kim
- Email: niawhz23@gmail.com
- Phone: +82-31-780-5858
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.