Actively Recruiting
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
Eligibility Criteria
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
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
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
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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