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

Asan Medical Center

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Procedure: percutaneous coronary intervention

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05807841

2020-0226

Details and patient eligibility

About

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).

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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