RADIOACTIVE CORONARY STENT WITH MULTIPLE HALF-LIVES

具有多个半衰期的放射性冠状动脉支架

• 批准号: 6015669
• 负责人: ANTHONY J ARMINI
• 金额: $ 10万
• 依托单位: IMPLANT SCIENCES CORPORATION
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-15 至 2001-03-21
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6015669
• 关键词: biomedical equipment development; blood vessel prosthesis; drug screening /evaluation; histology; medical implant science; nonhuman therapy evaluation; radionuclide implant; restenosis; swine; yttrium; biomedical equipment development; blood vessel prosthesis; drug screening /evaluation; histology; medical implant science; nonhuman therapy evaluation; radionuclide implant; restenosis; swine; yttrium

In 1995 about one million people worldwide had coronary blockages opened by dilatation. This procedure results in post--operative reclosure of the artery (restenosis) in about 30% of cases, despite insertion of a tiny mesh supporting tube (stent) at the blockage site. Recently, clinical exposures of the stented site to a very high dose rate from a "hot" iridium- 192 source mounted on a catheter tip have shown marked reduction in restenosis rates. A major disadvantage of this approach, the radiation safety problems associated with handling and inserting the source, are readily overcome with a low dose rate in vivo radioactive stent. Implant Sciences proposes to secure the advantages of both methods by testing stents employing two isotopes of greatly differing half-life, one designed to deliver a high dose rate for a short time, the other to provide the majority of the combined dose over a period of months. Using an existing ion implanter to activate stents with a 90Y/32P isotopic mixture, animal testing is proposed to evaluate the restenosis-inhibiting qualities of these devices. If they prove to be as effective as 192Ir, their thousand-times lower radioactivity should result in their acceptance as the preferred method of suppressing restenosis. PROPOSED COMMERCIAL APPLICATIONS: This research will lead to a process for ion implantation of radioisotopes into coronary stents. ISC has had interest from several stent manufacturers who plan to offer radioactive stents as soon as FDA approval is received. ISC plans to ion implant radioisotopes in their stents as a manufacturing service.

1995年，全世界约有100万人通过扩张开放冠状动脉堵塞。该程序导致大约30％病例的动脉（再狭窄）的术后重置，尽管在阻塞部位插入了微小的网状支撑管（支架）。最近，安装在导管尖端上的“热”虹膜源的临床暴露于非常高的剂量率，显示了再狭窄率的降低明显降低。 这种方法的主要缺点是，与处理和插入源相关的辐射安全问题很容易在体内放射性支架中以低剂量速率来克服。植入物科学建议通过测试使用两个大不相同的半衰期的同位素来确保两种方法的优势，一种旨在在短时间内提供高剂量率，另一种旨在在几个月内提供大多数合并剂量。提出了使用现有的离子植入剂激活90Y/32p同位素混合物的支架，提出了动物测试来评估这些设备的抑制再狭窄质量。如果它们被证明与192IR一样有效，那么千倍的放射性将导致他们作为抑制再狭窄的首选方法。拟议的商业应用：这项研究将导致放射性病植入冠状动脉支架的过程。 ISC感兴趣的是几家支架制造商的兴趣，他们计划在获得FDA批准后立即提供放射性支架。 ISC计划将植入放射性病的放射性分子作为制造服务。