Novel Collagen-Based Peripheral Endoprosthesis

描述（来自申请人的摘要的逐字）： 接受经皮腔内血管成形术（PTA）和血管内 用于治疗外周动脉粥样硬化病变患者的支架植入术，这些 这些技术存在一些缺点，这些缺点限制了它们的总体临床成功。 高再狭窄率仍然是PTA的主要并发症， 血管内支架植入术。本研究的总体目标是 设计、开发和体内测试新型胶原基内假体（CBE） 降低PTA术后再狭窄率。 在第一阶段的研究中，我们设计并开发了CBE原型 其可以通过标准的经腔经皮 干预技术。CBE原型的通畅率上级 犬股骨中基于ePTFE血管移植物的内假体原型 动脉模型在第二阶段，我们将进一步完善CBE的设计， 并评价CBE在动脉粥样硬化动物中的体内性能 模型在完成第二阶段的研究后，我们会继续进行第三阶段的研究 计划并积极进行CBE的临床试验和商业化 设备. 拟定商业应用： 仅在1995年，美国就有超过150，000例经皮腔内血管成形术（PTA）手术用于治疗外周动脉粥样硬化病变患者。晚期再狭窄的发生通常会导致再介入，从而导致患者护理总成本的显著增加。如果所提出的内假体装置功能良好，再狭窄率降低5%可以转化为每年节省超过1亿美元的相关医疗费用。

DESCRIPTION (Verbatim from the Applicant's Abstract): Despite the wide acceptance of percutaneous transluminal angioplasty (PTA) and intravascular stenting for treating patients with peripheral atherosclerotic lesions, these techniques suffer some drawbacks, which, limit their overall clinical success. A high rate of restenosis remains the major complication of PTA and intravascular stenting procedures. The overall goal of this research is to design, develop and test in vivo a novel collagen-based endoprosthesis (CBE) for reducing the rate of post-PTA restenosis. In the phase I investigation, we have designed and developed a CBE prototype that can be reliably delivered by standard transluminal percutaneous intervention techniques. The CBE prototype had a superior patency rate compared to an ePTFE vascular graft-based endoprosthesis prototype in a canine femoral artery model. In the phase II, we will further improve the design of the CBE, and evaluate the in vivo performance of the CBE in an atherosclerotic animal model. Upon completion of the phase II research, we will continue the phase III program and actively pursue clinical trials and commercialization of the CBE device. PROPOSED COMMERCIAL APPLICATION: There were more than 150,000 percutaneous transluminal angioplasty (PTA) procedures performed to treat patients with peripheral atherosclerotic lesions in the U.S. in 1995 alone. The occurrence of late restenosis typically lead to reinterventions that result in a significant increase of the total costs of patient care. If the proposed endoprosthesis device functions well, a 5% reduction of the restenosis rate can be translated into a savings of more than $100 million dollars a year in the associated healthcare costs.