A Novel Synthetic Vascular Graft Capable of Minimally Invasive Controlled Expansion for Vascular Reconstruction Model

一种新型合成血管移植物，能够微创控制扩张血管重建模型

• 批准号: 9914886
• 负责人: Arush Kalra
• 金额: $ 49.98万
• 依托单位: PECA LABS
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-04-15 至 2021-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9914886
• 关键词: Achievement; Address; Adult; Adverse event; Animal Model; Animals; Anxiety; Aorta; Balloon Dilatation; Blood Vessels; Caliber; Cardiac Surgery procedures; Cardiovascular Surgical Procedures; Cardiovascular system; Catheters; Chemicals; Child; Childhood; Clinical; Clinical Trials; Complex; Data; Deposition; Descending aorta; Devices; Economic Burden; Embolism; Endothelium; Etiology; Event; Failure; Family suidae; Goals; Gold; Goretex; Grant; Growth; Health; Health Care Costs; Human; Implant; Institutes; Intellectual Property; Intervention; Mechanics; Modeling; Newborn Infant; Obstruction; Operative Surgical Procedures; Parents; Pathway interactions; Patients; Peripheral; Personal Satisfaction; Phase; Polytetrafluoroethylene; Population; Postoperative Period; Property; Recurrence; Safety; Sheep; Site; Stenosis; Stents; Surface; Surgeon; Surgical sutures; Techniques; Technology; Testing; Texas; Thrombosis; Time; Trauma; Vascular Graft; Ventricular; age group; analog; biomaterial compatibility; commercialization; congenital heart disorder; design; experience; femoral artery; follow-up; homograft; implantation; in vivo; in vivo evaluation; manufacturing process; migration; minimally invasive; novel; phase 1 study; preclinical study; pressure; prototype; reconstruction; repaired; restenosis; success; uptake

PROJECT SUMMARY In pediatric cardiovascular surgery, no commercially available vascular conduit is capable of growing with the patient following implantation. This inability to grow with the patient is particularly relevant for newborns and young children because additional surgeries are required to replace the implanted conduit. In order to address this issue, PECA Labs has developed a novel cardiovascular conduit that can be expanded with a minimally invasive balloon catheter. This technology has been achieved by altering the properties of expanded- polytetrafluoroethylene (ePTFE) through a propriety manufacturing process. A prototype of PECA’s expandable conduit has successfully been developed, produced, and validated through benchtop, biocompatibility, and in vivo studies as well as successful achievement of CE Mark clearance for peripheral vascular use. Previous testing has illustrated the functionality of the proposed expandable ePTFE conduit (EEC), including resisting spontaneous expansion at normal pressures, yet being capable of expanding by dilation with a standard balloon catheter. Expansion to well over three times the original diameter has been demonstrated without compromising the mechanical strength. Furthermore, the applications of the technology are not limited to pediatric cardiovascular use, but also may provide significant benefits as a valved conduit and as a conduit for peripheral vascular reconstruction in adults. This significantly increases the market size and impact of the graft and with successful completion of benchtop, biocompatibility, and in vivo testing goals in Phase I. PECA Labs proposes the three specific aims to study the EEC in long term models – central vascular reconstruction with growth, valved conduit reconstruction, and peripheral vascular reconstruction. Specific Aim 1: The goal of this aim is to study two-stage expansions as well as to compare expansions of EEC with and without the use of covered stents. Additionally, it is valuable to understand two stages of expansion, observe overall large animal health post-first expansion, and to assess compatibility of covered stents with the EEC. Specific Aim 2: The goal of this aim is to use a valved configuration of the EEC to create the first valved conduit capable of providing growth potential, achieved by expanding the valved conduit and observing its functionality in conjunction with a commercially-available transcatheter valve. This application has the potential to reduce the number of repeat open-heart surgeries by three or more over the lifetime of the child. The design of these versions is derived from a clinically-proven valved conduit design, including the proprietary intellectual property licensed by PECA Labs. Specific Aim 3: The goal of this aim is to understand the benefits of EEC in adult peripheral vascular reconstruction. This will be achieved by comparing the implanted EEC with a gold-standard vascular graft for peripheral reconstruction and assessing the benefits of expansion to lengthen the overall time for which a peripheral graft can last in adult patients.

项目摘要 在儿科心血管外科手术中，没有市售的血管导管能够随着血管的生长而生长。 植入后患者。这种不能与患者一起成长的情况尤其与新生儿有关， 因为需要额外的手术来替换植入的管道。为了解决 在这个问题上，PECA实验室已经开发出一种新型的心血管管道， 侵入性球囊导管。这项技术是通过改变膨胀- 聚四氟乙烯（ePTFE）通过适当的制造工艺。PECA的原型 可膨胀导管已经成功地开发、生产，并通过实验台进行验证， 生物相容性、体内研究以及外周血管成功获得CE认证 血管使用。之前的测试已经说明了所提出的可膨胀ePTFE导管的功能 (EEC)，包括在正常压力下抵抗自发膨胀，但能够通过 用标准球囊导管扩张。扩张到原来直径的三倍多， 在不损害机械强度的情况下展示。此外，该技术的应用 不仅限于儿科心血管用途，还可作为带瓣管道提供显著益处 以及作为成人外周血管重建的导管。这大大增加了市场规模 以及移植物的影响，并成功完成实验室、生物相容性和体内试验目标 在第一阶段PECA实验室提出了在长期模型中研究EEC的三个具体目标： 生长血管重建、带瓣管道重建和外周血管重建。 具体目标1：该目标的目标是研究两阶段扩展以及比较 使用和不使用覆膜支架的EEC。此外，了解以下两个阶段是有价值的： 扩大，观察第一次扩大后的整体大型动物健康状况，并评估所涵盖的 支架与EEC。具体目标2：该目标的目标是使用EEC的带阀配置来创建 第一带瓣管道能够提供通过扩张带瓣管道实现的生长潜力，以及 观察其与市售的经导管瓣膜结合的功能。此应用程序有 在患者的生命周期内，有可能将重复心脏直视手术的次数减少三次或更多。 孩子这些版本的设计源自临床证明的带瓣管道设计，包括 由PECA Labs授权的专有知识产权。具体目标3：该目标的目标是了解 EEC在成人外周血管重建中的益处。这将通过比较 使用金标准血管移植物植入EEC进行外周重建，并评估 扩张以延长外周移植物在成人患者中持续的总时间。