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Fully automated quantitative coronary angiography versus optical coherence tomography guidance for coronary stent implantation (FLASH): Study protocol for a randomized controlled noninferiority trial

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Author(s)
Yongcheol KimHanbit ParkHyuck-Jun YoonJon SuhSi-Hyuck KangYoung-Hyo LimDuck Hyun JangJae Hyoung ParkEun-Seok ShinJang-Whan BaeJang Hoon LeeJun-Hyok OhDo-Yoon KangJihoon KweonMin-Woo JoDuk-Woo ParkYoung-Hak KimJung-Min Ahn
Keimyung Author(s)
Yoon, Hyuck Jun
Department
Dept. of Internal Medicine (내과학)
Journal Title
Am Heart J
Issued Date
2024
Volume
275
Abstract
Background:
Artificial intelligence-based quantitative coronary angiography (AI-QCA) has been developed to provide a more objective and reproducible data about the severity of coronary artery stenosis and the dimensions of the vessel for intervention in real-time, overcoming the limitations of significant inter- and intraobserver variability, and time-consuming nature of on-site QCA, without requiring extra time and effort. Compared with the subjective nature of visually estimated conventional CAG guidance, AI-QCA guidance provides a more practical and standardized angiography-based approach. Although the advantage of intravascular imaging-guided PCI is increasingly recognized, their broader adoption is limited by clinical and economic barriers in many catheterization laboratories.

Methods:
The FLASH (fully automated quantitative coronary angiography versus optical coherence tomography guidance for coronary stent implantation) trial is a randomized, investigator-initiated, multicenter, open-label, noninferiority trial comparing the AI-QCA-assisted PCI strategy with optical coherence tomography-guided PCI strategy in patients with significant coronary artery disease. All operators will utilize a novel, standardized AI-QCA software and PCI protocol in the AI-QCA-assisted group. A total of 400 patients will be randomized to either group at a 1:1 ratio. The primary endpoint is the minimal stent area (mm 2 ), determined by the final OCT run after completion of PCI. Clinical follow-up and cost-effectiveness evaluations are planned at 1 month and 6 months for all patients enrolled in the study.

Results:
Enrollment of a total of 400 patients from the 13 participating centers in South Korea will be completed in February 2024. Follow-up of the last enrolled patients will be completed in August 2024, and primary results will be available by late 2024.

Conclusion:
The FLASH is the first clinical trial to evaluate the feasibility of AI-QCA-assisted PCI, and will provide the clinical evidence on AI-QCA assistance in the field of coronary intervention.
Keimyung Author(s)(Kor)
윤혁준
Publisher
School of Medicine (의과대학)
Type
Article
ISSN
1097-6744
Source
https://www.clinicalkey.com/#!/content/playContent/1-s2.0-S0002870324001194
DOI
10.1016/j.ahj.2024.05.004
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/45738
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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