In vivo Characterization of Stents using Intravascular OCT Imaging

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DESCRIPTION (provided by applicant): Every year, 100s of thousands of patients in the US are treated with intravascular stents. Although the technology has advanced and drug eluting metal stents hinder restenosis, there remains significant room for improvement. Stent parameters include drug choice, bioresorbable versus metal, mechanical design, coatings to stimulate cell coverage, etc. To optimize designs, sensitive, in vivo assessments are needed for preclinical and clinical studies. Intravascular OCT (iOCT) alone provides the resolution and contrast s necessary for in vivo interrogation of vascular healing; stent deployment issues such as malposition; and assessment of stent strut tissue coverage. The Cardiovascular Imaging Core Laboratory at CWRU analyzes iOCT images as a service to numerous clinical and preclinical trials from around the world. An analyst takes many hours to analyze manually a single stent, greatly limiting the size and number of studies. Despite training and quality assurance measures, inter-analyst variability limits the ability to determine changes between stent types. We will develop highly automated software to greatly speed analysis, improve reproducibility, increase accuracy, etc. Careful evaluations/validations will be performed using our database of >1500 manually analyzed stents, and new phantom and pig studies. With the successful completion of this research and development, we will deliver well-validated, highly automated software, which will enable routine use of iOCT for sensitive evaluation of emerging stent technologies, thereby providing greatly improved treatments of cardiovascular disease. In addition, fast, robust software will contribute to clinical usage of iOCT for assessment of stent deployment and healing of a stented vessel.