Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07312318

AI-Driven Dynamic Prediction of Non-Target Lesion Progression After PCI: A Chinese Multicenter Cohort Study

Coronary artery disease remains a leading cause of global mortality. Although percutaneous coronary intervention (PCI) improves patient outcomes, the long-term risk of major adverse cardiovascular events (MACE) driven by the progression of non-target lesions (NTLs) remains substantial and continues to increase, while current risk stratification tools remain inadequate for predicting NTL progression. This multicenter cohort study aims to develop an artificial intelligence (AI)-driven system for the dynamic prediction and precision stratification of NTL progression after PCI. Utilizing comprehensive multimodal data from 52,577 Chinese patients-including clinical profiles, multi-omics blood biomarkers, and coronary imaging-the research pursues three primary objectives: (1) to identify and validate 2-3 specific biomarkers for NTL progression risk using multi-omics approaches; (2) to construct an integrated risk assessment and early-warning system by applying machine learning to multimodal data for predicting NTL progression and MACE; and (3) to establish metabolic and imaging-based subtypes to create a precision management system that optimizes secondary prevention strategies by identifying specific high-risk populations. This study is expected to provide a novel tool for accurate identification of high-risk patients and personalized post-PCI management, ultimately aiming to improve long-term prognosis.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Coronary Heart Disease (CHD) Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location status: Recruiting

Location contact

Fang Wang

CONTACT

[email protected]

+86 13683173633

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 years or older;
  • Scheduled for or having undergone PCI;
  • Baseline plasma sample obtainable;
  • Informed consent obtained

Exclusion criteria

  • Pregnancy or lactation;
  • Severe hepatic or renal dysfunction;
  • Active autoimmune disease;
  • Missing critical data

Treatment and study plan

percutaneous coronary intervention

Other

Percutaneous coronary intervention (PCI) represents a cornerstone therapeutic approach for coronary artery disease. This minimally invasive procedure involves vascular access typically through the radial or femoral artery, enabling the navigation of catheters and specialized devices to the culprit coronary lesion. The primary objective is to restore optimal coronary blood flow by addressing the obstructive lesion. The intervention encompasses various techniques including balloon angioplasty, stent implantation, and adjunctive procedures such as coronary atherectomy and thrombus aspiration when clinically indicated.

Primary outcomes

  1. Composite endpoint of NTL progression-related myocardial infarction or revascularization

    Time frame: 12 month follow-up

    • NTL progression-related myocardial infarction was defined in accordance with the fourth universal definition of myocardial infarction due to any segment of the nontarget vessel or lesion.
    • NTL progression-related revascularization was defined as revascularization driven by angina or ischemia, either PCI or CABG, of any segment of the nontarget vessel or lesion.

Secondary outcomes

  1. Qualitative data on NTL progression

    Time frame: 12 month follow-up

    The following conditions are defined as NTL progression: (1) NCL stenosis ≥50% at baseline PCI with ≥10% NCL progression at angiographic follow-up; (2) NCL stenosis <50% at baseline PCI with ≥30% NCL progression at angiographic follow-up; (3) NCL progression ≥30% without NCL at baseline PCI; (4) NCL progression to complete occlusion. Quantitative data for NTL progression (QCA) are obtained by analyzing coronary angiographic images to determine lesion progression.

  2. Quantitative data on NTL progression

    Time frame: 12 month follow-up

    QCA analyzes coronary angiography images to determine the progression of lesions: Coronary angiography was evaluated by two independent cardiologists who were unaware of all other clinical data of the patients, using the MEDCON TCS QCA software. First, the edges of the contrast-enhanced vessels were delineated using an automatic edge detection algorithm. After identifying the starting and ending points on the enhanced coronary images, a vascular path was created. Subsequently, the vessel contour was drawn along the path. The path and vessel contour were automatically determined based on contrast density, with occasional manual editing required by the analysts. Measured variables included minimum lumen diameter and degree of lumen stenosis (minimum lumen diameter/adjacent contrast vessel diameter).

  3. NTL progression-related myocardial infarction

    Time frame: 12 month follow-up

    NTL progression-related myocardial infarction was defined in accordance with the fourth universal definition of myocardial infarction due to any segment of the nontarget vessel or lesion.

  4. NTL progression-related revascularization

    Time frame: 12 month follow-up

    NTL progression-related revascularization was defined as revascularization driven by angina or ischemia, either PCI or CABG, of any segment of the nontarget vessel or lesion.

Study contacts

Contact information is provided by the study sponsor or research team.

Fang Wang

CONTACT

[email protected]

+86 13683173633

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Collaborators

  • Peking Union Medical College

Registry information

Official study title

DeVelopment of an Artificial Intelligence-Driven Dynamic Prediction and Precision Stratification System for Coronary Non-Target LesIon ProgressiON After Percutaneous Coronary Intervention: A Multimodal Data-Enabled Multicenter Cohort Study in China

Acronym: VISION-PCI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.