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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05807841
• Other study ID #: 2020-0226
• Status: Recruiting
• Start date: February 20, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2023
• Source: Asan Medical Center
• Contact: Soo-Jin Kang, MD
• Phone: 82-10-8982-2604
• Email: sjkang[@]amc.seoul.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• percutaneous coronary intervention
IVUS-guided stent implantation

Locations

Country	Name	City	State
Korea, Republic of	Soon Chun Hyang University Hospital Bucheon	Bucheon
Korea, Republic of	Gosin University Gospel Hospital	Busan
Korea, Republic of	Inje University Pusan Paik Hospital	Busan
Korea, Republic of	Gyeongsang National University Changwon Hospital	Changwon
Korea, Republic of	Kangwon National University Hospital	Chuncheon
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	The Catholic university of korea, daejeon st. mary's hospital	Daejeon
Korea, Republic of	Gangneung Asan Hospital	Gangneung
Korea, Republic of	Jesushospital	Jeonju
Korea, Republic of	Chungnam National University Sejong Hospital	Sejong
Korea, Republic of	Kangbuk Samsung Medical Center	Seoul
Korea, Republic of	Seung-Whan Lee	Seoul
Korea, Republic of	The Catholic university of korea, Eunpyeong st. mary's hospital	Seoul
Korea, Republic of	Veterans Hospital Service Medical Center	Seoul
Korea, Republic of	The Catholic University of Korea ST.VINCENT'S Hospital	Suwon
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Boston Scientific Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	nonculprit-related TVF	composite of cardiac death, MI, and clinically-driven TVR at 2 years	2 years after stent implantation
Secondary	each component of primary measures	each of cardiac death, non-fetal MI, ST and target vessel revascularization	2 years after stent implantation
Secondary	all cause death	all cause death	2 years after stent implantation
Secondary	repeat revascularization	repeat revascularization	2 years after stent implantation
Secondary	stroke	stroke	2 years after stent implantation
Secondary	bleeding	bleeding	2 years after stent implantation