NCT06985693 Medipixel XA-Assisted PCI in Coronary Artery Disease
| NCT ID | NCT06985693 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CHA University |
| Condition | Percutaneous Coronary Intervention (PCI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 830 participants |
| Start Date | 2025-05-15 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 830 participants in total. It began in 2025-05-15 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06985693 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Percutaneous Coronary Intervention (PCI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06985693 currently recruiting?
Yes, NCT06985693 is actively recruiting participants. Contact the research team at niawhz23@gmail.com for enrollment information.
Where is the NCT06985693 trial being conducted?
This trial is being conducted at Gwangmyeong, South Korea, Seongnam-si, South Korea, Daegu, South Korea, Gwangju, South Korea and 2 additional locations.
Who is sponsoring the NCT06985693 clinical trial?
NCT06985693 is sponsored by CHA University. The trial plans to enroll 830 participants.