Stent Coating to Prevent Restenosis and Subacute Thrombosis

描述（由申请人提供）：这项快速通道SBIR申请提出了一种涂层的改进和临床前测试，该涂层旨在抑制血管内支架的再狭窄和血栓形成。这项研究计划将建立在使用涂层原型进行动物试验的令人鼓舞的结果之上。在第一阶段，将通过全面分析系统变量并验证涂层应用的每个步骤中的涂层性能来优化涂层工艺。将进行初步的生物相容性测试，以确定涂层对血液和组织的局部影响。在满足规定的工艺要求和生物相容性要求后，该项目将进入第二阶段，在第二阶段，涂层过程将在自动化、受控的应用设备中实施。涂层支架将进行广泛的耐久性测试。正在计划进行动物实验，以研究该支架在分离血管模型中的活性。最后，将在28天的猪植入模型中对支架进行评估。涂层被设计为一个独立的解决方案，以提高支架的性能；然而，涂层可以很容易地与其他涂层或药物释放剂结合。

DESCRIPTION (provided by applicant): This fast track SBIR application proposes the refinement and preclinical testing of a coating designed to inhibit restenosis and thrombosis in intravascular stents. The research plan will build on encouraging results from pilot animal studies with coated prototypes. During Phase I, the coating process will be optimized by thoroughly analyzing system variables and verifying coating properties in each step of the coating application. Preliminary biocompatibility testing will be conducted, to identify local effects of the coating on blood and tissue. Upon meeting defined process requirements and biocompatibility requirements, the project will move to Phase II, where the coating process will be implemented in an automated, controlled application apparatus. The coated stents will undergo extensive durability testing. Animal studies are planned that will investigate the activity of the stent in an isolated vessel model. Finally, the stents will be evaluated in a 28-day porcine implant model. The coating is designed as a stand-alone solution to improve stent performance; however, the coating can be combined readily with other coatings or drug-release agents.