Actively Recruiting

Age: 19Years +
All Genders
NCT05807841

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

Led by Asan Medical Center · Updated on 2024-12-27

3000

Participants Needed

16

Research Sites

488 weeks

Total Duration

On this page

Sponsors

A

Asan Medical Center

Lead Sponsor

B

Boston Scientific Corporation

Collaborating Sponsor

AI-Summary

What this Trial Is 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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Subjects who sign the informed consent form
Not Eligible

You will not qualify if you...

  • ST-segment elevation myocardial infarction at admission
  • Patients who underwent coronary artery bypass surgery or heart transplantation
  • Left ventricular ejection fraction less than 30%
  • Cardiogenic shock
  • Patients with life expectancy less than 2 years
  • Women who are breastfeeding, pregnant, or planning pregnancy during the study
  • Patients contraindicated for anti-platelets or heparin
  • Left main culprit lesion with angiographic diameter stenosis over 50%
  • Thrombus-containing lesion
  • In-stent restenosis
  • Side branch lesion
  • Chronic total occlusion
  • Small vessel with reference diameter less than 2.5 mm
  • Coronary spasm despite nitrate administration
  • Inability for imaging catheter to pass tight stenosis, calcification, or angulations
  • Poor image quality
  • Angiographically visible collateral vessels

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 16 locations

1

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, South Korea

Actively Recruiting

2

Gosin University Gospel Hospital

Busan, South Korea

Actively Recruiting

3

Inje University Pusan Paik Hospital

Busan, South Korea

Actively Recruiting

4

Gyeongsang National University Changwon Hospital

Changwon, South Korea

Actively Recruiting

5

Kangwon National University Hospital

Chuncheon, South Korea

Actively Recruiting

6

Keimyung University Dongsan Medical Center

Daegu, South Korea

Actively Recruiting

7

The Catholic university of korea, daejeon st. mary's hospital

Daejeon, South Korea

Actively Recruiting

8

Gangneung Asan Hospital

Gangneung, South Korea

Actively Recruiting

9

Jesushospital

Jeonju, South Korea

Actively Recruiting

10

Chungnam National University Sejong Hospital

Sejong, South Korea

Actively Recruiting

11

Seung-Whan Lee

Seoul, South Korea, 05505

Actively Recruiting

12

Kangbuk Samsung Medical Center

Seoul, South Korea

Not Yet Recruiting

13

The Catholic university of korea, Eunpyeong st. mary's hospital

Seoul, South Korea

Actively Recruiting

14

Veterans Hospital Service Medical Center

Seoul, South Korea

Actively Recruiting

15

The Catholic University of Korea ST.VINCENT'S Hospital

Suwon, South Korea

Actively Recruiting

16

Ulsan University Hospital

Ulsan, South Korea

Actively Recruiting

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Research Team

S

Seung-Whan Lee, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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