In vivo Characterization of Stents using Intravascular OCT Imaging

使用血管内 OCT 成像对支架进行体内表征

• 批准号: 8529140
• 负责人: Hiram Bezerra
• 金额: $ 41.29万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-01 至 2017-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8529140
• 关键词: Algorithms; Ally; Area; Arteries; Back; Biological Markers; Blood Vessels; Cardiac; Cardiovascular Diseases; Catheters; Cells; Characteristics; Classification; Clinical; Clinical Management; Clinical Research; Clinical Trials; Code; Color; Computer software; Data; Databases; Dependence; Detection; Development; Devices; Evaluation; Family suidae; Feedback; Fibrin; Fracture; Goals; Graph; Healed; Histocompatibility Testing; Hour; Hyperplasia; Image; Image Analysis; Imagery; Industry; International; Laboratories; Licensing; Life; Machine Learning; Manuals; Manufacturer Name; Measurement; Measures; Mechanics; Metals; Methods; Modeling; Myocardial Ischemia; Needs Assessment; Optics; Pathology; Patients; Pharmaceutical Preparations; Polymers; Process; Property; Reporting; Reproducibility; Resolution; Sampling; Scanning; Services; Shadowing (Histology); Shapes; Simulate; Site; Speed; Statistical Data Interpretation; Stents; Techniques; Technology; Testing; Thick; Thrombosis; Time; Tissue Sample; Tissues; Training; Universities; Validation; Vascular Diseases; arm; base; cardiovascular imaging; cost; design; follow-up; healing; imaging modality; implantation; improved; in vivo; innovation; meetings; novel; preclinical evaluation; preclinical study; public health relevance; quality assurance; research and development; research clinical testing; restenosis; tool

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.

描述（由申请人提供）：每年，美国有100千名患者接受血管内支架治疗。尽管该技术已经进步和洗脱金属支架阻碍了再狭窄，但仍有很大的改进空间。支架参数包括药物选择，可生物吸收与金属，机械设计，刺激细胞覆盖的涂层等。以优化设计，敏感的，体内评估的临床前和临床研究需要进行体内评估。仅血管内OCT（IOCT）提供了血管愈合体内询问所需的分辨率和对比度；支架部署问题，例如故障；并评估支架支撑组织覆盖率。 CWRU中的心血管成像核心实验室分析IOCT图像，作为来自世界各地众多临床和临床前试验的服务。分析师需要花费数小时来分析手动单个支架，这极大地限制了研究的大小和数量。尽管采取了训练和质量保证措施，但分析师的变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，以极大的速度分析，提高可重复性，提高准确性等。仔细评估/验证将使用我们的数据库进行> 1500个手动分析的支架以及新的幻影和猪研究。随着这项研究和开发的成功完成，我们将提供精心验证的高度自动化软件，这将使IOCT常规使用对新兴支架技术的敏感评估，从而极大地改善了心血管疾病的治疗方法。此外，快速，健壮的软件将有助于IOCT的临床使用，以评估支架船的支架部署和愈合。