Clinical Impact of Intravascular Ultrasound-Based Artificial Intelligence Technologies (INNOVATE-PCI)
NCT ID: NCT05807841
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
3000 participants
OBSERVATIONAL
2020-02-20
2029-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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percutaneous coronary intervention
IVUS-guided stent implantation
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Asan Medical Center
OTHER
Responsible Party
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Seung-Whan Lee, M.D., Ph.D.
Principal Investigator
Principal Investigators
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Seung-Whan Lee, MD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Soon Chun Hyang University Hospital Bucheon
Bucheon-si, , South Korea
Gosin University Gospel Hospital
Busan, , South Korea
Inje University Pusan Paik Hospital
Busan, , South Korea
Gyeongsang National University Changwon Hospital
Changwon, , South Korea
Kangwon National University Hospital
Chuncheon, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
The Catholic university of korea, daejeon st. mary's hospital
Daejeon, , South Korea
Gangneung Asan Hospital
Gangneung, , South Korea
Jesushospital
Jeonju, , South Korea
Chungnam National University Sejong Hospital
Sejong, , South Korea
Seung-Whan Lee
Seoul, , South Korea
Kangbuk Samsung Medical Center
Seoul, , South Korea
The Catholic university of korea, Eunpyeong st. mary's hospital
Seoul, , South Korea
Veterans Hospital Service Medical Center
Seoul, , South Korea
The Catholic University of Korea ST.VINCENT'S Hospital
Suwon, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Yoon-Haeng Cho, MD
Role: primary
Jeong-Ho Heo, MD
Role: primary
Tae-Hyun Yang, MD
Role: primary
Jae-Seok Bae, MD
Role: primary
Bong-Ki Lee, MD
Role: primary
Cheol-Hyeon Lee, MD
Role: primary
Kyu-Sup Lee, MD
Role: primary
Han-Bit Park, MD
Role: primary
Jong-Pil Park, MD
Role: primary
Jae-Hwan Lee, MD
Role: primary
Seung-Whan Lee, MD
Role: primary
Jong-Young Lee, MD
Role: primary
Jung-hoon Lee, MD
Role: primary
Chang-Hoon Lee, MD
Role: primary
Sung-Ho Her, MD
Role: primary
Gyung-Min Park, MD
Role: primary
Other Identifiers
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2020-0226
Identifier Type: -
Identifier Source: org_study_id