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

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 2025, 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 15 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

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

Study Locations

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

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Between February 2020 and June 2025, 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 15 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Seung-Whan Lee, MD, Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2020
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: March 29, 2023
• First Posted (Actual): April 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: machine learning; percutaneous coronary intervention; artificial intelligence; intravascular ultrasound; coronary angiography
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease
• Other Study ID Numbers: 2020-0226

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