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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Heart Disease (CHD)
• Intervention / Treatment: Other: percutaneous coronary intervention

• Study Type: Observational
• Enrollment (Estimated): 12000

Contacts and Locations

• Study Contact: Name: Fang Wang; Phone Number: +86 13683173633; Email: wangfang@cjfh.org.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Fang Wang; Phone Number: +86 13683173633; Email: wangfang@cjfh.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study integrates three dedicated Chinese cohorts of post-PCI coronary artery disease patients, comprising two cohorts provided by the National Population Health Data Center and one consecutive cohort recruited from the Department of Cardiology at China-Japan Friendship Hospital.

Description

Inclusion Criteria:

1. Aged 18 years or older;
2. Scheduled for or having undergone PCI;
3. Baseline plasma sample obtainable;
4. Informed consent obtained

Exclusion Criteria:

1. Pregnancy or lactation;
2. Severe hepatic or renal dysfunction;
3. Active autoimmune disease;
4. Missing critical data

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite endpoint of NTL progression-related myocardial infarction or revascularization	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.	12 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative data on NTL progression	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.	12 month follow-up
Quantitative data on NTL progression	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).	12 month follow-up
NTL progression-related myocardial infarction	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.	12 month follow-up
NTL progression-related revascularization	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.	12 month follow-up

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Collaborators: Peking Union Medical College
• Investigators: Principal Investigator: Fang Wang, China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Artificial Intelligence; coronary heart disease; Non-Target LesIon Progression
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Coronary Disease; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Percutaneous Coronary Intervention
• Other Study ID Numbers: 2025-NHLHCRF-PY-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No