Multi-Functional Guidewire for Peripheral Vasculature

描述（由申请人提供）：超过800万美国人患有外周血管疾病（PAD）。重度PAD的经皮腔内动脉（PTA）治疗涉及球囊和支架的使用，但由于血管造影评估血管尺寸不准确或缺乏适当的功能血管评估，这些治疗的输送通常不理想。其他工具可帮助临床医生准确确定血管尺寸和功能，但由于需要额外的时间、成本、培训和解释，这些工具通常未被使用。导丝用于每种介入手术，因此导丝不仅能够为治疗输送提供稳定的平台，而且能够为血管结构和功能提供诊断工具，这将是有价值的。我们开发了一种功能齐全的0.035”LumenRECON（LR）导丝，其机械性能与标准Wholey workhorse导丝相同，但也使用电阻抗技术评估血管管腔尺寸和狭窄压降。因此，导丝提供了三合一功能（即，一根主力导丝充当治疗输送、血管尺寸测量和狭窄压降评估的平台）。在本I期提案中，我们将进行一项临床前研究，以确认我们的0.035”LumenRECON（LR）导丝作为血管导航的标准主力导丝以及大型动物管腔尺寸和压降测量的准确诊断工具的功能。为了实现I期目标，将在家猪中评估尺寸测量（特定目标#1）和压降（特定目标#2）测量的安全性、沿着准确性和可重复性，并根据当前临床使用的工具进行测量，例如血管内超声（IVUS）、定量血管造影（QA）和压力导丝。这项建议针对的是艾滋病在全国范围内日益严重流行的问题，并涉及一个日益严重但往往被忽视的领域。成功完成拟议的目标将使我们能够将我们的研究成果转化为一种可以大大改善PAD治疗的设备。

DESCRIPTION (provided by applicant): Over 8 million Americans have peripheral vascular disease (PAD). Percutaneous transluminal artery (PTA) treatment of severe PAD involves the use of balloons and stents, but delivery of these therapies is often suboptimal due to inaccuracies in angiographic assessment of vessel size or a lack of proper functional vessel assessment. Additional tools aid clinicians in accurately determining vessel size and function, but these are often unused because of the added time, cost, training, and interpretation required. Guidewires are used in every interventional procedure, so the ability of a guidewire to provide not only a stable platform for therapy delivery, but also a diagnostic tool for vessel structure and function would be valuable. We have developed a fully functional 0.035" LumenRECON (LR) guidewire that has the same mechanical properties as a standard Wholey workhorse guidewire, but also uses electrical impedance technology to assess vessel lumen size and stenosis pressure drop. Thus, the guidewire provides a 3-in-1 functionality (i.e. one workhorse guidewire that acts as a platform for therapy delivery, vessel sizing, and stenosis pressure drop assessment). In this Phase I proposal, we will perform a pre-clinical study to validate the functionality of our 0.035" LumenRECON (LR) guidewire as a standard workhorse guidewire for vessel navigation and an accurate diagnostic tool for luminal sizing and pressure drop measurements in large animals. To accomplish the Phase I objectives, the safety, along with accuracy and repeatability of the sizing (specific aim #1) and pressure drop (specific aim #2) measurements will be assessed in domestic swine and measured against current clinically used tools, such as intravascular ultrasound (IVUS), quantitative angiography (QA), and pressure wires. This proposal addresses the significant and growing national epidemic of PAD and addresses an area that is growing, yet often overlooked. Successful completion of the proposed Aims will allow us to translate our research findings into a device that could drastically improve the treatment of PAD.