The purpose of this study will be to detect the prevalence and prognostic value of plaque temperature heterogeneity in diabetic patients undergoing stent implantation. The objective is to develop and commercialize an intraluminal Thermal Sensing System (TSS) for taking surface temperature measurements of atherosclerotic plaque lesions within the walls of coronary arteries with the goal that current and future means to prevent coronary events can be implemented selectively. The system comprises an invasive catheter and an external instrument. The device has been validated in vitro and in vivo. A pilot human study involving patients undergoing angioplasty for medically indicated reasons was completed successfully.
Specific Aims for the proposed SBIR Phase II are: [1] Advance the current intraluminal TSS toward a commercially viable product - change to thermocouples, improve catheter flexibility, reduce sensing element profile, integrate an occlusion feature - followed by revalidation of System safety and performance. [2] Demonstrate in a human clinical trial the predictive value of plaque surface temperature for future ischemic events and validate the performance of the TSS. After this grant we have plans in place to commercialize the technology including design for manufacturability, additional clinical studies, and a market development strategy for this exciting and useful new diagnostic device.
