Clinical trial NCT06985693: Medipixel XA-Assisted PCI in Coronary Artery Disease
Official title: Medipixel XA-Assisted Percutaneous Coronary Intervention in Coronary Artery Disease: A Prospective Multicenter Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Percutaneous Coronary Intervention (PCI)
Coronary Arterial Disease (CAD)
Keywords: Artificial Intelligence
Quantitative Coronary Analysis
Medipixel
MPXA
Lead sponsor: CHA University
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 830
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Target Vessel Failure (TVF)
timeFrame: 12 months post-procedure
Secondary outcomes:
measure: Minimal Lumen Diameter (MLD) Assessed by MPXA
timeFrame: Immediately post-procedure
measure: Residual Stenosis (%) Assessed by MPXA
timeFrame: Immediately post-procedure
measure: MPXA Success Rate
timeFrame: Immediately post-procedure
measure: Death
timeFrame: 12 months post-procedure
measure: Myocardial Infarction
timeFrame: 12 months post-procedure
measure: Revascularization
timeFrame: 12 months post-procedure
measure: Stent Thrombosis
timeFrame: 12 months post-procedure
measure: Incidence of Periprocedural Complications
timeFrame: Immediately post-procedure
measure: Rate of Proper Pre-Dilation Balloon Selection
timeFrame: Immediately post-procedure
measure: Rate of Proper Stent Sizing Selection
timeFrame: Immediately post-procedure
measure: Frequency of Post-Dilation
timeFrame: Immediately post-procedure
measure: Rate of Proper Post-Dilation Balloon Selection
timeFrame: Immediately post-procedure
Other outcomes:
measure: Types and Frequency of Additional Interventions Following Intravascular Imaging During PCI
timeFrame: Immediately post-procedure
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center
state: Gyeonggi-do
city: Gwangmyeong
country: Korea, Republic of
facility: Chung-Ang University Gwangmyeong Hospital
state: Gyeonggi
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Jeonju
country: Korea, Republic of
facility: Presbyterian Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
References:
citation: Kim Y, Yoon HJ, Suh J, Kang SH, Lim YH, Jang DH, Park JH, Shin ES, Bae JW, Lee JH, Oh JH, Kang DY, Kweon J, Jo MW, Yun SC, Park DW, Kim YH, Park SJ, Park H, Ahn JM; FLASH Trial Investigators. Artificial Intelligence-Based Fully Automated Quantitative Coronary Angiography vs Optical Coherence Tomography-Guided PCI: The FLASH Trial. JACC Cardiovasc Interv. 2025 Jan 27;18(2):187-197. doi: 10.1016/j.jcin.2024.10.025. Epub 2024 Oct 30.
citation: Lee SY, Zhang JJ, Mintz GS, Hong SJ, Ahn CM, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Kan J, Pan T, Gao X, Ge Z, Chen SL, Hong MK. Procedural Characteristics of Intravascular Ultrasound-Guided Percutaneous Coronary Intervention and Their Clinical Implications. J Am Heart Assoc. 2022 Jul 19;11(14):e025258. doi: 10.1161/JAHA.122.025258. Epub 2022 Jul 15.