Percutaneous Coronary Intervention (PCI)MAP INCT06985693
Medipixel XA-Assisted PCI in Coronary Artery Disease
A study testing Medipixel XA-Assisted Percutaneous Coronary Intervention in people with Percutaneous Coronary Intervention (PCI) and Coronary Arterial Disease (CAD), run by CHA University at 6 sites in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention (PCI), Coronary Arterial Disease (CAD)
- What is being tested?
- Medipixel XA-Assisted Percutaneous Coronary Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 830 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 15 May 2025to May 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Silent ischemia, stable or unstable angina, or myocardial infarction
- De novo coronary lesion eligible for DES implantation
- Lesions analyzable by MPXA
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
South Korea6 sites, 6 recruiting
- Recruiting
Keimyung University Dongsan Medical Center
Daegu, 42601
Yoon-Joo Bae, +82-53-258-4006, yoonjoo99999@naver.com
Hyuck-Jun Yoon
- Recruiting
Chonnam National University Hospital
Gwangju, 61469
Min-Jee Kim, +82-62-220-6016, minkky12@hanmail.net
Seung Hun Lee
- Recruiting
Chung-Ang University Gwangmyeong Hospital
Gwangmyeong, Gyeonggi-do, 14351
Ji-Sook Seo, +82-2-6299-1114, jsseo007@cauhs.or.kr
Jun Hwan Cho
- Recruiting
Presbyterian Medical Center
Jeonju, 54987
Jong Pil Park, +82-1899-1843, jppark74@gmail.com
Jong Pil Park
- Recruiting
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, 13496
Hwa-In Kim, +82-31-780-5858, niawhz23@gmail.com
Seung-Yul Lee
- Recruiting
Ulsan University Hospital
Ulsan, 44033
Min-Jung Park, +82-52-250-7000, 0903738@uuh.ulsan.kr
Gyung-Min Park
About this study
Official title: Medipixel XA-Assisted Percutaneous Coronary Intervention in Coronary Artery Disease: A Prospective Multicenter Study
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.
- Being tested
- Medipixel XA-Assisted Percutaneous Coronary Intervention
- Keywords
- Artificial Intelligence, Quantitative Coronary Analysis, Medipixel, MPXA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medipixel XA-Assisted Percutaneous Coronary InterventionProcedure or surgery
Also called MPXA-PCI
Medipixel XA-Assisted Percutaneous Coronary Intervention (MPXA-PCI) is an AI-assisted coronary intervention procedure utilizing Medipixel XA (MPXA), an artificial intelligence-based quantitative coronary analysis (AI-QCA) software. MPXA analyzes angiographic images in real-time to assist in lesion assessment, optimal balloon and stent selection, and procedural decision-making during percutaneous coronary intervention (PCI).
In this study, all participants will undergo MPXA-assisted PCI, where the software provides automated vessel segmentation, diameter measurement, and lesion quantification to optimize procedural outcomes. Operators will follow a predefined protocol incorporating MPXA measurements for balloon sizing, stent selection, and post-dilation strategies.
The study evaluates the safety, feasibility, and clinical impact of MPXA-assisted PCI in real-world coronary artery disease patients.
| Study group | Role | What they receive |
|---|---|---|
| Medipixel XA-Assisted PCI Group | Experimental | Not described Receives: Procedure: Medipixel XA-Assisted Percutaneous Coronary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Vessel Failure (TVF)
Target vessel failure (TVF) is a composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularization (TVR).
Measured: 12 months post-procedure
Secondary outcomes (12)
Minimal Lumen Diameter (MLD) Assessed by MPXA
Post-PCI minimal lumen diameter as measured by Medipixel XA.
Measured: Immediately post-procedure
Residual Stenosis (%) Assessed by MPXA
Percentage of remaining stenosis in the treated lesion, as analyzed by MPXA.
Measured: Immediately post-procedure
MPXA Success Rate
Defined as residual stenosis <20% as assessed by Medipixel XA and TIMI 3 flow in the target vessel.
Measured: Immediately post-procedure
Death
Measured: 12 months post-procedure
Myocardial Infarction
Measured: 12 months post-procedure
Revascularization
Measured: 12 months post-procedure
Stent Thrombosis
Measured: 12 months post-procedure
Incidence of Periprocedural Complications
Rate of complications such as coronary dissection, perforation, and no-reflow phenomenon.
Measured: Immediately post-procedure
Rate of Proper Pre-Dilation Balloon Selection
Proportion of cases where pre-dilation balloon size was chosen according to MPXA analysis.
Measured: Immediately post-procedure
Rate of Proper Stent Sizing Selection
Proportion of cases where the stent size was selected according to MPXA recommendations.
Measured: Immediately post-procedure
Frequency of Post-Dilation
Number of cases where post-dilation was performed
Measured: Immediately post-procedure
Rate of Proper Post-Dilation Balloon Selection
Proportion of cases where the balloon size adhered to MPXA recommendations.
Measured: Immediately post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start15 May 2025
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Coronary Intervention (PCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 830 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung-Yul Lee, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985693
- Sponsor's protocol ID
- CHAMC IRB 2025-02-065-001
- Acronym
- MAP I
- Status last verified
- Oct 2026
- First submitted
- 15 May 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39614852Lee 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.
PubMed 35861828