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

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).