A Multicenter Feasibility and Safety Study of a Novel Hybrid IVUS-OCT Imaging System

JACC. Asia Pub Date : 2025-03-01 DOI:10.1016/j.jacasi.2025.01.009

Qinhua Jin MD , Zhenhong Fu MD , Yupeng Wang MD , Yong Zeng MD , Xiaoling Zhang MD , Yicong Ye MD , Yida Tang MD , Xinye Xu MD , Yundai Chen MD, PhD

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引用次数: 0

Abstract

Currently, precise stent manipulation and placement in percutaneous coronary intervention remain compromised. Intravascular imaging techniques are often limited by either spatial resolution or depth of penetration. A hybrid intravascular ultrasound (IVUS)-optical coherence tomography (OCT) system would be a better choice for interventional cardiologists. To validate the image quality and safety of the novel IVUS-OCT system for guiding coronary intervention in Chinese patients, a total of 114 cases were included. The proportion of clear imaging length was 96.21% ± 10.16%. Device success rate was 99.1%, technical success rate was 98.2%, and excellent image rate was 96.5%. No catheter-related adverse events occurred, and the incidence of device defects was 0.9%. This study preliminarily verified the image quality and safety of the novel Hybrid IVUS and OCT imaging system. (The StUdy to Evaluate the Performance and safEty of the Novasight HybRid System Using Objective PeRformance Criteria [SUPERIOR]; NCT04617899)

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一种新型混合IVUS-OCT成像系统的多中心可行性和安全性研究

目前，在经皮冠状动脉介入治疗中，精确的支架操作和放置仍然存在问题。血管内成像技术通常受到空间分辨率或穿透深度的限制。血管内超声(IVUS)-光学相干断层扫描（OCT）混合系统将是介入心脏病专家更好的选择。为了验证新型IVUS-OCT系统用于指导中国患者冠状动脉介入治疗的图像质量和安全性，共纳入114例病例。清晰成像长度比例为96.21%±10.16%。器械成功率99.1%，技术成功率98.2%，优像率96.5%。无导管相关不良事件发生，器械缺陷发生率为0.9%。本研究初步验证了新型IVUS和OCT混合成像系统的图像质量和安全性。基于目标性能标准的Novasight混合动力系统性能与安全性评价研究[SUPERIOR]；NCT04617899)

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来源期刊

JACC. Asia Cardiology and Cardiovascular Medicine

CiteScore

4.00

自引率

0.00%

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