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）。经皮腔内动脉（PTA）治疗严重PAD涉及使用球囊和支架，但由于血管造影评估血管大小不准确或缺乏适当的血管功能评估，这些治疗的递送往往不是最佳的。额外的工具可以帮助临床医生准确地确定血管的大小和功能，但由于增加了时间、成本、培训和解释要求，这些工具通常未被使用。导丝在每一种介入手术中都有使用，因此导丝不仅可以为治疗提供稳定的平台，还可以作为血管结构和功能的诊断工具，这将是有价值的。我们开发了一种功能齐全的0.035英寸LumenRECON （LR）导丝，它具有与标准Wholey主力车导丝相同的机械性能，但也使用电阻抗技术来评估血管管腔大小和狭窄压降。因此，导丝提供了三合一的功能（即一个主力军导丝作为治疗递送、血管大小和狭窄压降评估的平台）。在这个I期提案中，我们将进行临床前研究，以验证我们的0.035“LumenRECON （LR）导丝作为船舶导航的标准主导丝的功能，以及用于大型动物管腔尺寸和压降测量的准确诊断工具。为了完成第一阶段的目标，将在家猪中评估尺寸（特定目标#1）和压降（特定目标#2）测量的安全性、准确性和可重复性，并与当前临床使用的工具（如血管内超声（IVUS）、定量血管造影（QA）和压力线）进行测量。这一建议解决了严重和日益严重的非洲PAD国家流行病，并解决了一个不断增长但往往被忽视的领域。成功完成所提出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.