Stent Coating to Prevent Restenosis and Subacute Thrombosis

描述(申请人提供)：这一快速通道SBIR应用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。该研究计划将建立在用涂层原型进行动物试验的令人鼓舞的结果的基础上。在第一阶段，将通过彻底分析系统变量并在涂装应用的每个步骤中验证涂装性能来优化涂装工艺。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兼容性要求后，该项目将进入第二阶段，在此阶段，涂层过程将在自动化、受控的应用设备中实施。涂层支架将接受广泛的耐久性测试。正在计划进行动物研究，以研究支架在隔离血管模型中的活性。最后，支架将在28天的猪植入模型中进行评估。该涂层被设计为一种独立的解决方案，以提高支架性能；然而，该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.