RecruitingNCT05807841
Clinical Impact of Intravascular Ultrasound-Based Artificial Intelligence Technologies (INNOVATE-PCI)
Influence of Novel Intravascular Ultrasound-Based Artificial Intelligence Technologies on Event Reduction Following Percutaneous Coronary Intervention (INNOVATE-PCI)
Sponsor
Asan Medical Center
Enrollment
3,000 participants
Start Date
Feb 20, 2020
Study Type
OBSERVATIONAL
Conditions
Summary
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).
Eligibility
Min Age: 19 Years
Inclusion Criteria4
- 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
Exclusion Criteria17
- 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
- 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
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Interventions
PROCEDUREpercutaneous coronary intervention
IVUS-guided stent implantation
Locations(16)
View Full Details on ClinicalTrials.gov
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NCT05807841
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