Multi-Functional Guidewire for Peripheral Vasculature

描述(申请人提供)：超过800万美国人患有外周血管疾病(PAD)。严重PAD的经皮腔内动脉(PTA)治疗涉及球囊和支架的使用，但由于血管造影对血管大小的评估不准确或缺乏适当的功能血管评估，这些治疗往往是次优的。额外的工具有助于临床医生准确确定血管的大小和功能，但由于所需的额外时间、成本、培训和解释，这些工具通常没有使用。导丝用于每一种介入操作，因此导丝不仅能为治疗提供稳定的平台，而且还能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，它具有与标准Wholey主力导丝相同的机械性能，但还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，一个主要的导丝作为提供治疗、血管大小和狭窄压降评估的平台)。在这项第一阶段计划中，我们将进行一项临床前研究，以验证我们的0.035英寸LumenRECON(LR)导丝作为标准主力导丝的功能，以及用于大型动物的管腔大小和压力降测量的准确诊断工具。为了实现第一阶段的目标，将在家猪中评估大小(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，并对照当前临床使用的工具进行测量，如血管内超声(IVUS)、定量血管造影术(QA)和压力线。这项建议解决了PAD在全国范围内日益严重的流行问题，并解决了一个正在增长但往往被忽视的领域。成功完成拟议的AIMS将使我们能够将我们的研究成果转化为一种设备，可以显著改善PAD的治疗。

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.