In vivo Characterization of Stents using Intravascular OCT Imaging

描述（由申请人提供）：美国每年有数十万患者接受血管内支架治疗。虽然技术已经进步，药物洗脱金属支架可以阻止再狭窄，但仍有很大的改进空间。支架参数包括药物选择、生物可吸收性与金属、机械设计、刺激细胞覆盖的涂层等。为了优化设计，临床前和临床研究需要进行敏感的体内评估。血管内OCT（iOCT）单独提供了血管愈合体内询问所需的分辨率和对比度;支架展开问题，如错位;以及支架支柱组织覆盖评估。CWRU的心血管成像核心实验室分析iOCT图像，为世界各地的众多临床和临床前试验提供服务。分析师需要数小时才能手动分析单个支架，这极大地限制了研究的规模和数量。尽管采取了培训和质量保证措施，但分析员之间的差异性限制了确定支架类型之间变化的能力。我们将开发高度自动化的软件，以大大加快分析速度，提高再现性，提高准确性等。将使用我们的>1500个手动分析支架的数据库以及新的体模和猪研究进行仔细的评价/确认。随着这项研究和开发的成功完成，我们将提供经过充分验证的高度自动化软件，这将使iOCT能够常规用于新兴支架技术的敏感评价，从而大大改善心血管疾病的治疗。此外，快速、稳健的软件将有助于iOCT在临床上用于评估支架展开和支架血管愈合。

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.