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

Sponsor

Asan Medical Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05807841

Collaborator

Boston Scientific Corporation (Industry)

3,000

Enrollment

Locations

64.3

Anticipated Duration (Months)

200

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	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 Design

Study Type:

Observational

Anticipated Enrollment :

3000 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 20, 2020

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Jun 30, 2025

Outcome Measures

Primary Outcome Measures

culprit-related TVF [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
nonculprit-related TVF [2 years after stent implantation]
composite of cardiac death, MI, and clinically-driven TVR at 2 years

Secondary Outcome Measures

each component of primary measures [2 years after stent implantation]
each of cardiac death, non-fetal MI, ST and target vessel revascularization
all cause death [2 years after stent implantation]
all cause death
repeat revascularization [2 years after stent implantation]
repeat revascularization
stroke [2 years after stent implantation]
stroke
bleeding [2 years after stent implantation]
bleeding

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Soon Chun Hyang University Hospital Bucheon	Bucheon	Korea, Republic of
2	Gosin University Gospel Hospital	Busan	Korea, Republic of
3	Inje University Pusan Paik Hospital	Busan	Korea, Republic of
4	Gyeongsang National University Changwon Hospital	Changwon	Korea, Republic of
5	Kangwon National University Hospital	Chuncheon	Korea, Republic of
6	Keimyung University Dongsan Medical Center	Daegu	Korea, Republic of
7	The Catholic university of korea, daejeon st. mary's hospital	Daejeon	Korea, Republic of
8	Gangneung Asan Hospital	Gangneung	Korea, Republic of
9	Jesushospital	Jeonju	Korea, Republic of
10	Chungnam National University Sejong Hospital	Sejong	Korea, Republic of
11	Seung-Whan Lee	Seoul	Korea, Republic of	05505
12	Kangbuk Samsung Medical Center	Seoul	Korea, Republic of
13	Veterans Hospital Service Medical Center	Seoul	Korea, Republic of
14	The Catholic University of Korea ST.VINCENT'S Hospital	Suwon	Korea, Republic of
15	Ulsan University Hospital	Ulsan	Korea, Republic of