Physio-Anatomy Clinical Data Collection
This is an on-label clinical study design intended for the collection of three different types of interventional procedural data using FDA-cleared cardiac catheterization technologies and drugs, each used according to its product labeling and standard practice of medicine. These devices and drugs are commonly used for patient evaluation during PCI procedures performed by Interventional Cardiologists.
The three device technologies used in a single catheterization laboratory (“cath lab”) visit for assessment of the coronary arteries include:
• A coronary angiography imaging system to X-ray the coronary arteries for the evaluation of vessel narrowing or blocking.
• Pressure guidewire from one or more manufacturers for the measurement of coronary physiology parameters
• Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging catheter for imaging and sizing of the stenosed coronary arteries.
The data collected according to this data collection protocol will be used to develop novel enhanced diagnostic capabilities of the Gentuity HF-OCT Imaging System. Specifically, these data will be used for software and algorithm development of computational fluid dynamic (CFD) methodologies for image-based physiological assessment calculations.
Primary Investigator: Jarrod Frizzell