Novel Collagen-Based Peripheral Endoprosthesis

新型胶原蛋白外周内置假体

• 批准号: 6337227
• 负责人: SHU-TUNG T LI
• 金额: $ 23.27万
• 依托单位: COLLAGEN MATRIX, INC.
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-15 至 2003-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6337227
• 关键词: angiography; atherosclerosis; biomaterial compatibility; biomaterial development /preparation; biomaterial evaluation; blood vessel prosthesis; collagen; histology; intraluminal angioplasty; medical implant science; miniature swine; restenosis; scanning electron microscopy

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.

描述（逐字摘自申请人摘要）：尽管广泛 接受经皮腔内血管成形术（PTA）和血管内治疗 支架置入术用于治疗外周动脉粥样硬化病变患者， 技术存在一些缺点，这限制了它们的整体临床成功。 高再狭窄率仍然是 PTA 的主要并发症 血管内支架置入手术。这项研究的总体目标是 设计、开发和体内测试新型胶原蛋白内置假体 (CBE) 用于降低 PTA 术后再狭窄的发生率。 在第一阶段的研究中，我们设计并开发了CBE原型机 可以通过标准经皮腔内可靠地输送 干预技术。相比之下，CBE 原型具有更高的通畅率 犬股骨中基于 ePTFE 血管移植物的内置假体原型 动脉模型。在第二阶段，我们将进一步完善CBE的设计， 并评估 CBE 在动脉粥样硬化动物中的体内性能 模型。 II期研究完成后，我们将继续III期研究 计划并积极开展 CBE 的临床试验和商业化 设备。 拟议的商业应用： 仅 1995 年，美国就进行了超过 150,000 例经皮腔内血管成形术 (PTA) 手术来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重新干预，从而导致患者护理总成本显着增加。如果所提出的内置假体装置运行良好，再狭窄率降低 5%，每年可节省超过 1 亿美元的相关医疗费用。