Rapid assessment of vascular grafts patency

血管移植物通畅性的快速评估

• 批准号: 7227814
• 负责人: HANSEN A MANSY
• 金额: $ 44.01万
• 依托单位: BIOMEDICAL ACOUSTICS RESEARCH COMPANY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-05-01 至 2009-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7227814
• 关键词: Abdominal Aortic Aneurysm; Accounting; Acoustics; Affect; Angiography; Applications Grants; Blood Vessels; Blood flow; Bypass; Caliber; Cardiac; Carotid Arteries; Clinical Research; Condition; Data; Detection; Development; Devices; Engineering; Evaluation; Fistula; Goals; Gold; Hand; Hemodialysis; Home environment; Individual; Interventional radiology; Kidney; Lead; Marketing; Measurement; Medical Surveillance; Methodology; Methods; Modeling; Modification; Monitor; Numbers; Organ Transplantation; Outcome Study; Patients; Performance; Peripheral arterial disease; Phase; Pilot Projects; Placement; Primary Health Care; Recommendation; Renal dialysis; Research Personnel; Severities; Signal Transduction; Skin; Standards of Weights and Measures; Stenosis; Stethoscopes; Surface; Technology; Testing; Tetradecanoylphorbol Acetate; Training; Ultrasonography; United States; United States Food and Drug Administration; Vascular Graft; base; computerized; cost; human study; instrument; programs; prototype; sensor; sound; tool

DESCRIPTION (provided by applicant): The long-term objective of this project is the introduction of "smart stethoscope" technology to immediately, accurately, safely, easily and inexpensively detect blood vessel compromise using computerized analysis of vascular sounds. The specific goal of this project is to develop a device for surveillance of vascular bypass grafts, and renal hemodialysis access grafts and fistulas. The final product will not only detect the presence of stenosis but also its degree of severity. Advantages of the device include: high accuracy, non- invasiveness, low cost, ease of use, minimal training requirements, and immediate results. The Phase I effort focused on renal dialysis access grafts and fistulas, and showed high accuracy (p <.0001), in the detection of even small changes (<20%) in vessel caliber with a correlation coefficient of 0.92 compared to interventional radiology. Our Phase I data also suggested that some engineering modifications will likely enhance the device performance and lead to an even more clinically useful tool. During Phase II, we will test and implement specific engineering modifications, and fabricate prototypes for use in clinical studies of vascular bypass grafts, and renal hemodialysis grafts or fistulas. Study outcomes will include evaluations of accuracy, ease of use, training requirements, cost, and patient acceptance compared to the competing technologies of ultrasound dilution, and duplex US. The studies will take into account FDA recommendations for obtaining premarket approval, and we will seek a PMA or 510k approval from the FDA based upon study results. The potential market for our instrument is large given the number of individuals with either bypass grafts, or hemodialysis grafts or fistulas.

描述（由申请人提供）：该项目的长期目的是引入“智能听诊器”技术，可以通过计算机化的血管声音分析，准确，安全，轻松，轻松，廉价地检测血管妥协。该项目的具体目标是开发一种用于监视血管旁路移植物以及肾脏血液透析接口移植物和瘘管的装置。最终产品不仅将检测狭窄的存在，而且还将检测其严重程度。该设备的优点包括：高精度，非侵入性，低成本，易用性，最少的培训要求和立即结果。 I期的工作重点是肾脏透析接收移植物和瘘管，并且在检测到较小的变化（<20％）（<20％）的血管口径中，与介入放射学相比，相关系数为0.92。我们的I阶段数据还表明，某些工程修改可能会提高设备性能并导致更具临床上有用的工具。在第二阶段，我们将测试和实施特定的工程修饰，并制作原型用于血管旁路移植物以及肾血液透析移植物或瘘管的临床研究。与超声稀释的竞争技术相比，研究成果将包括对准确性，易用性，培训要求，成本和患者接受的评估，以及US Duplex US。这些研究将考虑FDA获取前市场批准的建议，我们将根据研究结果从FDA获得PMA或510K批准。鉴于具有旁路移植物或血液透析移植物或瘘管的个体的数量，我们乐器的潜在市场很大。