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Recruiting NCT05807841

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

— Observational Coronary Artery Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: percutaneous coronary intervention.
Who it may be relevant to
Registry conditions: Coronary Artery Disease. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

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.

Interventions

  • Procedure percutaneous coronary intervention
    IVUS-guided stent implantation

Primary outcome measures

  • culprit-related TVF [Time frame: 2 years after stent implantation]
  • nonculprit-related TVF [Time frame: 2 years after stent implantation]
Secondary outcome measures (5)
  • each component of primary measures [Time frame: 2 years after stent implantation]
  • all cause death [Time frame: 2 years after stent implantation]
  • repeat revascularization [Time frame: 2 years after stent implantation]
  • stroke [Time frame: 2 years after stent implantation]
  • bleeding [Time frame: 2 years after stent implantation]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

South Korea · 16 centers
  • Soon Chun Hyang University Hospital Bucheon — Bucheon-si
  • Gosin University Gospel Hospital — Busan
  • Inje University Pusan Paik Hospital — Busan
  • Gyeongsang National University Changwon Hospital — Changwon
  • Kangwon National University Hospital — Chuncheon
  • Keimyung University Dongsan Medical Center — Daegu
  • The Catholic university of korea, daejeon st. mary's hospital — Daejeon
  • Gangneung Asan Hospital — Gangneung
  • … and 8 more centers

Identifiers

NCT: NCT05807841 · 2020-0226

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗