Permanent Vasodilators for Improved Angioplasty

描述(由申请人提供)： 血管成形术已被证明是治疗血管阻塞的有效方法。然而，在最初的成功之后，许多血管成形术部位会发生再狭窄，导致进一步的治疗、医疗费用和人类痛苦。延长血管成形术部位的通畅率是一个迫切的需要。这项拟议工作的目标是测试一种新的治疗剂，用于快速和局部扩张血管成形部位，使其超出球囊本身的直径。这项建议描述了调查治疗剂的有效性和安全性的关键概念验证研究。该提案的目的是证明在血管成形术中，通过直接壁内治疗，血管管腔直径立即和持续增加，并确定治疗对血管抗张强度的影响。具体目标的完成和里程碑标准的成功实现将使该项目进入第二阶段，该阶段将包括临床前研究，目标是提交研究性新药申请。在第三阶段，将进行临床研究，最终目标是将一种新的治疗药物商业化，以防止血管成形术后的再狭窄和闭塞，提高患者的生活质量，并减轻公共卫生保健负担。

DESCRIPTION (provided by applicant): Angioplasty has proved to be an effective treatment for vascular obstruction. After initial success, however, restenosis occurs at many angioplasty sites, leading to further treatment, health care expenses and human suffering. A critical need exists to prolong the patency of angioplasty sites. The goal of the proposed work is to test a novel therapeutic agent in the rapid and local dilation of angioplasty sites beyond the diameter of the balloon itself. This proposal describes key proof-of-concept studies investigating the efficacy and safety of the therapeutic agent. The goals of the proposal are to demonstrate immediate and persistent gains in vessel lumen diameter with direct intramural treatment during angioplasty and to determine the effects of treatment on vessel tensile strength. Completion of the specific aims and-successful achievement of milestone criteria will allow the project to progress to Phase II, which will consist of pre-clinical studies with the goal of submitting an Investigational New Drug application. In Phase III, clinical studies will be undertaken with the ultimate goal of commercializing a new therapeutic agent to prevent restenosis and occlusion following angioplasty, improving patient quality of life and reducing public health care burdens.