AN INTRAVASCULAR X-RAY SOURCE FOR RESTENOSIS TREATMENT

用于再狭窄治疗的血管内 X 射线源

• 批准号: 6310290
• 负责人: RUTH E SHEFER
• 金额: $ 52.31万
• 依托单位: NEWTON SCIENTIFIC, INC.
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-05-01 至 2003-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6310290
• 关键词: X ray; biomedical equipment development; catheterization; coronary artery; coronary disorder; disease /disorder prevention /control; energy source; intraluminal angioplasty; miniature biomedical equipment; phantom model; radiation dosage; radiation therapy; restenosis

DESCRIPTION (Applicant's abstract verbatim): The goal of this project is to develop a miniature, catheter-based X-ray source for radiation therapy to prevent restenosis after percutaneous transluminal angioplasty. Restenosis affects 30 percent to 50 percent of angioplasty patients within six months of the procedure. Intravascular radiation therapy has been shown to be effective in preventing or significantly delaying restenosis in both coronary and peripheral vessels. Ongoing clinical trials of intravascular brachytherapy for restenosis use gamma or beta-emitting radioisotopes delivered to the angioplasty site via a guide catheter and withdrawn when sufficient dose has been delivered to the arterial segment. These radioactive devices have significant drawbacks, including limited dose rates and fixed dose-depth profiles, safety hazards to patient and medical personnel, and restrictions on transportation, storage and disposal. In Phase I, we evaluated the feasibility of developing a disposable, electrically-powered X-ray source small enough to reach the angioplasty site through a standard guide catheter. Advantages of the proposed source include on-off capability, high radiation dose rate, user-controlled dose-depth profile, and elimination of the regulatory and safety issues that accompany the use of radioactive materials. The Phase I results demonstrate the feasibility of constructing an ultra-miniature X-ray source with the required radiation dose rate and dose-depth characteristics. A fully operational X-ray source and delivery catheter will be developed in Phase II and tested in phantoms. PROPOSED COMMERCIAL APPLICATION: Approximately 1,000,000 coronary angioplasty procedures are performed worldwide each year. If radiation therapy for restenosis is proven effective in clinical trials, this represents a large market for catheter-based radiation devices. A flexible, catheter-based X-ray source also has many potential applications in radiation oncology.

描述（申请人的摘要逐字）：本项目的目标是 开发一种用于放射治疗的微型导管X射线源， 预防经皮腔内血管成形术后再狭窄。再狭窄 影响了30%到50%的血管成形术患者， 程序血管内放射治疗已被证明是有效的 在预防或显著延迟冠状动脉和 外周血管正在进行的血管内近距离放射治疗的临床试验 再狭窄使用γ或β发射放射性同位素递送到 血管成形术部位通过引导导管，并撤回足够的剂量时， 被输送到动脉段。这些放射性装置 显著的缺点，包括有限的剂量率和固定的剂量深度 对患者和医务人员的安全危害，以及 运输、储存和处置。 在第一阶段，我们评估了开发一次性， 小到足以到达血管成形术部位的电动X射线源 通过一个标准的引导导管拟议来源的优点包括 开关能力，高辐射剂量率，用户控制剂量深度 概况，并消除监管和安全问题，伴随着 使用放射性物质。第一阶段的结果表明， 建造一个超小型的X射线源 剂量率和剂量深度特性。一个全面运作的X射线源， 输送导管将在II期开发并在体模中进行试验。 拟定商业应用： 全世界约有1，000，000例冠状动脉血管成形术 每年. 如果再狭窄的放射治疗在临床试验中被证明有效， 代表了基于导管的放射装置的巨大市场。 一种灵活的、基于导管的 X射线源在放射肿瘤学中也有许多潜在的应用。