C-73 | Advancing Coronary Imaging: Augmented Hybrid NIRF-IVUS Technology for Improved Detection of Coronary

Coronary artery dissections from PCI and spontaneous coronary artery dissection (SCAD) can be life-threatening and require accurate diagnosis. Early recognition and prompt management of coronary dissection are crucial in preventing catastrophic consequences such as LV dysfunction, cardiogenic shock, periprocedural MI, or cardiac death. While IVUS is widely employed in interventional cardiology for lesion characterization and procedural guidance, its limitations in resolution and tissue contrast hinder its efficacy in diagnosing stent-edge dissection (SED) and SCAD. SED, linked to increased early stent thrombosis, is particularly challenging to detect with stand-alone IVUS, with a reported sensitivity as low as 20%. Additionally, distinguishing SCAD from lipid-rich atheroma is hindered by IVUS's inherent spatial resolution limitations. The Augmented Hybrid NIRF-IVUS technology developed by i3 Intravascular Imaging Inc. seamlessly integrates a high-definition IVUS catheter with NIRF (Near-Infrared Fluorescence) imaging. The system employs Indocyanine Green (ICG) fluorescence to significantly enhance the detection of SED and SCAD. I3's system is a miniaturized 3.0F NIRF-IVUS catheter. Rigorous in vitro, ex vivo and in vivo studies demonstrated the device's superior capability to detect and illuminate preclinical and human coronary vessel pathologies. Notably, NIRF-IVUS with ICG is superior to stand-alone IVUS in detecting PTCA-induced dissection and lipid-rich, inflamed plaques. A FIH clinical trial is planned to evaluate the efficacy and safety of i3 Hybrid NIRF-IVUS with ICG augmentation, in enhancing the detection of coronary artery dissection, particularly in SED, compared to angiography alone. This cutting-edge technology addresses a critical unmet need in SED and SCAD detection. The integration of ICG fluorescence with NIRF holds the promise to overcome the limitations of IVUS imaging, providing enhanced visualization and characterization of coronary dissections while enabling molecular imaging of coronary plaques. This innovation is poised for seamless integration into clinical practice, marking a significant advancement in coronary imaging technology.