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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
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

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Keimyung University - Dongsan Medical Center
Coordinator of this site? Confirm its status
DaeguSouth KoreaRecruiting
Chonnam National University Hospital
Coordinator of this site? Confirm its status
GwangjuSouth KoreaRecruiting
Chung-Ang University Gwangmyeong Hospital
Coordinator of this site? Confirm its status
GwangmyeongSouth KoreaRecruiting
Presbyterian Medical Center
Coordinator of this site? Confirm its status
JeonjuSouth KoreaRecruiting
CHA Bundang Medical Center
Coordinator of this site? Confirm its status
Seongnam-siSouth KoreaRecruiting
Ulsan University Hospital
Coordinator of this site? Confirm its status
UlsanSouth KoreaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.