CORONARY STENTS WITH ION IMPLANTED RADIOACTIVITY

具有离子注入放射性的冠状动脉支架

• 批准号: 6183369
• 负责人: ANTHONY J ARMINI
• 金额: $ 37.24万
• 依托单位: IMPLANT SCIENCES CORPORATION
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 2002-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6183369
• 关键词: biomaterial development /preparation; biomedical equipment development; blood vessel prosthesis; coronary artery; evaluation /testing; heart catheterization; medical implant science; palladium; radionuclide implant; restenosis; swine

Catheter-based temporary radiation therapy following balloon angioplasty has been shown in clinical studies to reduce restenosis. This program is concerned with developing a permanently implanted radioactive stent which can also reduce restenosis. In Phase I, Implant Sciences demonstrated that a coronary stent could be ion implanted with radioactivity accurately and uniformly and without any wash-off of radioactivity from the stent surface. Also a special radioactive ion source was designed for an existing ion implanter which could safely handle the radioactive source material. In Phase II we plan to answer some perplexing questions raised by some European clinical studies which have shown more restenosis beyond each end of the radioactive stent than within the stent boundaries. This will be done using a porcine animal model. These studies will also compare a low energy x-ray emitter 103Pd with the beta emitter 32P using the same target dose at the adventia of the coronary artery. The animal study, to be done at the Washington Hospital Center will evaluate the degree of restenosis and late lumen loss at 1,3, and 6 month intervals both within and beyond the stent boundaries. PROPOSED COMMERCIAL APPLICATIONS: This research could lead to the high volume ion implantation of coronary stents with radioactive isotopes. Radioactive stents have been shown to markedly reduce restenosis after angioplasty. Implant Sciences Corporation plans to offer the ion implantation as a service to stent manufacturers.

在临床研究中已经显示了基于导管的基于导管的临时放射疗法，以减少再狭窄。该程序涉及开发永久植入的放射性支架，该支架也可以减少再狭窄。在第一阶段，植入物科学表明，冠状动脉支架可以准确，均匀地植入放射性，而不会从支架表面擦掉放射性。还为现有的离子植入器设计了一种特殊的放射性离子源，该离子植入器可以安全地处理放射性材料。在第二阶段，我们计划回答一些欧洲临床研究提出的一些令人困惑的问题，这些问题显示出比放射性支架两端的再狭窄多于支架边界内。这将使用猪动物模型完成。这些研究还将使用冠状动脉膜的相同目标剂量将低能X射线发射器103pd与Beta发射器32p进行比较。在华盛顿医院中心进行的动物研究将评估恢复病的程度和后期管腔损失的程度为1,3，间隔为6个月的间隔和超越支架边界内外。拟议的商业应用：这项研究可能导致带有放射性同位素的冠状动脉支架的大容量离子植入。放射性支架已显示可显着减少血管成形术后再狭窄。 植入科学公司计划提供离子植入作为支架制造商的服务。