Clinical Impact of Intravascular Ultrasound-Based Artificial Intelligence Technologies (INNOVATE-PCI)

June 23, 2026 updated by: Seung-Whan Lee, M.D., Ph.D., Asan Medical Center

Influence of Novel Intravascular Ultrasound-Based Artificial Intelligence Technologies on Event Reduction Following Percutaneous Coronary Intervention (INNOVATE-PCI)

This study is a prospective, multicenter study in the real practice to validate the diagnostic performances and clinical impact of coronary angiography & intravascular ultrasound (IVUS)-based models developed by machine learning (ML).

Study Overview

Status

Recruiting

Conditions

Coronary Artery Disease

Intervention / Treatment

Procedure: percutaneous coronary intervention

Detailed Description

The aim of the study is to evaluate the performances and prognostic impact of coronary angiography & IVUS-based algorithms for decision making and stent optimization in a multicenter, prospective cohort. Between January 2020 and June 2027, a total of 3,000 patients who performed coronary angiography (± FFR) and have at least one coronary stenosis requiring PCI (as culprit) will be enrolled from 16 centers in South Korea. In addition, the deferred lesions with visual estimated diameter stenosis of >30% will be evaluated as non-culprits. Brief study design is as depicted in the following figure.

Supervised ML algorithms include: 1) angiography- and IVUS-based algorithms for predicting FFR, 2) IVUS-based algorithm for plaque characterization, 3) IVUS-based algorithm for predicting stent expansion, and 4) post-stenting IVUS-based algorithm for predicting stent failure. In the prospective cohort, the performance of each model will be assessed. This registry trial composed of the treated (culprit) and the deferred (nonculprit) coronary lesions has two primary objectives as follow; 1) Primary objectives in treated (culprit) lesions is to see the impact of the integrated ML model on the development of culprit-related 2-year target vessel failure (TVF). 2) Primary objectives in deferred (nonculprit) lesions is to see the impact of the integrated ML model on the development of nonculprit-related 2-year TVF.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Seung-Whan Lee, MD
Phone Number: 82-10-7398-9897
Email: seungwlee@amc.seoul.kr

Study Locations

South Korea
- - Bucheon-si, South Korea
    - Recruiting
    - Soon Chun Hyang University Hospital Bucheon
    - Contact:
      
      Yoon-Haeng Cho, MD
    - Principal Investigator:
      
      Yoon-Haeng Cho, MD
  - Busan, South Korea
    - Recruiting
    - Inje University Pusan Paik Hospital
    - Contact:
      
      Tae-hyun Yang, MD
    - Principal Investigator:
      
      Tae-hyun Yang, MD
  - Busan, South Korea
    - Recruiting
    - Gosin University Gospel Hospital
    - Contact:
      
      Jeong-Ho Heo, MD
    - Principal Investigator:
      
      Jeong-Ho Heo, MD
  - Changwon, South Korea
    - Recruiting
    - Gyeongsang National University Changwon Hospital
    - Contact:
      
      Jae-seok Bae, MD
    - Principal Investigator:
      
      Jae-seok Bae, MD
  - Chuncheon, South Korea
    - Recruiting
    - Kangwon National University Hospital
    - Contact:
      
      Bong-ki Lee, MD
    - Principal Investigator:
      
      Bong-ki Lee, MD
  - Daegu, South Korea
    - Recruiting
    - Keimyung University Dongsan Medical Center
    - Contact:
      
      Cheol-Hyeon Lee, MD
    - Principal Investigator:
      
      Cheol-Hyeon Lee, MD
  - Daejeon, South Korea
    - Recruiting
    - The Catholic University of Korea, Daejeon ST. Mary's Hospital
    - Contact:
      
      Kyu-Sup Lee, MD
    - Principal Investigator:
      
      Kyu-Sup Lee, MD
  - Gangneung, South Korea
    - Recruiting
    - Gangneung Asan Hospital
    - Contact:
      
      Han-bit Park, MD
    - Principal Investigator:
      
      Han-bit Park, MD
  - Jeonju, South Korea
    - Recruiting
    - Jesushospital
    - Contact:
      
      Jong-Pil Park, MD
    - Principal Investigator:
      
      Jong-Pil Park, MD
  - Sejong, South Korea
    - Recruiting
    - Chungnam National University Sejong Hospital
    - Principal Investigator:
      
      Jae-Hwan Lee, MD
    - Contact:
      
      Jae-Hwan Lee, MD
  - Seoul, South Korea
    - Recruiting
    - The Catholic University of Korea, Eunpyeong St. Mary's Hospital
    - Contact:
      
      Jung-Hoon Lee, MD
    - Principal Investigator:
      
      Jung-Hoon Lee, MD
  - Seoul, South Korea
    - Recruiting
    - Veterans Hospital Service Medical Center
    - Contact:
      
      Chang-Hoon Lee, MD
    - Principal Investigator:
      
      Chang-Hoon Lee, MD
  - Seoul, South Korea, 05505
    - Recruiting
    - Seung-Whan Lee
    - Contact:
      
      Seung-Whan Lee, MD
      
      Phone Number: 82-10-7398-9897
      
      Email: seungwlee@amc.seoul.kr
  - Seoul, South Korea
    - Not yet recruiting
    - Kangbuk Samsung Medical Center
    - Principal Investigator:
      
      Jong-Young Lee, MD
    - Contact:
      
      Jong-Young Lee, MD
  - Suwon, South Korea
    - Recruiting
    - The Catholic University of Korea ST.VINCENT'S Hospital
    - Contact:
      
      Sung-ho Her, MD
    - Principal Investigator:
      
      Sung-ho Her, MD
  - Ulsan, South Korea
    - Recruiting
    - Ulsan University Hospital
    - Contact:
      
      Gyung-Min Park, MD
    - Principal Investigator:
      
      Gyung-Min Park, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Between February 2020 and June 2027, a total of 3,000 patients who performe coronary angiography (± FFR) and have at least one coronary stenosis requiring PCI (as culprit) will be enrolled from 16 centers in South Korea.

Description

Inclusion Criteria:

Age 19 years or older
Symptomatic angina patients with objective myocardial ischemia
Patients with at least one major epicardial coronary artery that requires stent implantation
Subject who signs with informed consent form

Patient exclusion Criteria:

ST-segment elevation MI at admission
Patients who underwent coronary artery bypass surgery or heart transplantation
Left ventricular ejection fraction <30%
Cardiogenic shock
Patients whose life expectancy <2 years
Woman who are breastfeeding, pregnant or planning to become pregnant during study
Patients in whom anti-platelets or heparin is contraindicated

Lesion exclusion Criteria:

Left main culprit lesion (angiographic diameter stenosis >50%)
Thrombus-containing lesion
In-stent restenosis
Side branch lesion
Chronic total occlusion
Small vessel with reference diameter <2.5mm
Coronary spasm despite administration of nitrate
Inability for imaging catheter to pass through tight stenosis, calcification, angulations
Poor image quality
Angiographically visible collateral vessels

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
culprit-related TVF Time Frame: 2 years after stent implantation	composite of cardiac death, myocardial infarction (MI), stent thrombosis, and clinically-driven target vessel revascularization (TVR) at 2 years after SynergyTM implantation	2 years after stent implantation
nonculprit-related TVF Time Frame: 2 years after stent implantation	composite of cardiac death, MI, and clinically-driven TVR at 2 years	2 years after stent implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
each component of primary measures Time Frame: 2 years after stent implantation	each of cardiac death, non-fetal MI, ST and target vessel revascularization	2 years after stent implantation
all cause death Time Frame: 2 years after stent implantation	all cause death	2 years after stent implantation
repeat revascularization Time Frame: 2 years after stent implantation	repeat revascularization	2 years after stent implantation
stroke Time Frame: 2 years after stent implantation	stroke	2 years after stent implantation
bleeding Time Frame: 2 years after stent implantation	bleeding	2 years after stent implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Boston Scientific Corporation

Investigators

Principal Investigator: Seung-Whan Lee, MD, Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2020

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria