Non-Invasive Physiologic Evaluation of Peripheral Arterial Disease

周围动脉疾病的无创生理学评估

• 批准号: 10004703
• 负责人: Thomas Bruce Ferguson
• 金额: $ 52.46万
• 依托单位: RFPI, LLC
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-05 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10004703
• 关键词: Address; Adult; Affect; Age; Aged, 80 and over; Amputation; Anatomy; Angiography; Animal Testing; Ankle; Atherosclerosis; Automobile Driving; Blood Pressure; Blood Vessels; Blood flow; Cardiovascular Diseases; Cardiovascular system; Caring; Cerebrovascular Disorders; Characteristics; Cholesterol; Clinic; Clinical; Computer software; Conflict (Psychology); Data; Data Analyses; Diabetes Mellitus; Diagnostic; Disease; Dyes; Engineering; Enrollment; Evaluation; FDA approved; Guidelines; Health Personnel; Healthcare; Hypertension; Image; Imaging technology; Institutional Review Boards; Ionizing radiation; Lower Extremity; Measurement; Metabolism; Modification; Myocardial; Myocardial Ischemia; Normal Range; Operative Surgical Procedures; Optics; Organ; Oxygen; Patients; Perfusion; Peripheral; Peripheral Vascular Diseases; Peripheral arterial disease; Phase; Physiological; Physiology; Population; Recommendation; Research; Risk Factors; Sensitivity and Specificity; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Smoking; Societies; Specificity; Stenosis; Symptoms; Testing; Time; Tissues; Training; Universities; Visualization; Walking; aging population; base; care delivery; claudication; commercialization; comorbidity; design; diabetic; engineering design; evaluation/testing; falls; image visualization; improved; indexing; medical specialties; meetings; novel; novel imaging technology; performance tests; phantom model; pre-clinical; product development; prototype; research clinical testing; screening

ABSTRACT Peripheral Arterial Disease (PAD) is a substantial healthcare burden in the US (estimated > 8M) and around the world (estimated > 200M). In the aging population, over 24% with age > 80 years have PAD. 50% of all patients with PAD are asymptomatic, and up to 40% of the remaining patients have atypical symptoms. The conventional ankle/brachial index (cABI) ratio is established as the initial diagnostic evaluation in symptomatic patients presenting for PAD evaluation, with high sensitivity and specificity. Unfortunately, the sensitivity falls off substantially when applied to asymptomatic/atypical patients and the use of cABI as a screening test is highly controversial. The USPSTF recommendations are in conflict with cardiovascular medical specialty society guidelines. Therefore, an improved approach to evaluating these asymptomatic/atypical subsets of PAD patients is an unmet need in healthcare, and the solution is an important quality opportunity. The STTR Phase I (R43HL133633-01A1) results, and preliminary data for a submitted SBIR (R43HL146579- 01, pending resubmission), are driving a unique approach to meeting this healthcare need. Recent data suggest that the fall off in sensitivity is related to the physiologic changes in end-organ tissues due to co- morbidities and risk factors. The SBC RFPi, Inc. proposes to integrate non-invasive, non-contact systolic blood pressure threshold determination  ABI ratio (Phase I) with peripheral oxygen determination (SBIR), with further integration into RFPi’s novel imaging technology solution Multi-spectral Physiologic Visualization (MSPV) (first form factor FDA approved 12/14/18). MPSV non-invasively (no dyes or ionizing radiation) and without patient contact analyzes and displays blood flow distribution physiology (flow in vessels and perfusion in tissues) in target tissues in true real-time. This 3-factor integration product, called MSPVO2-ABI, will provide the physiologic data augmentation needed to improve sensitivity in the evaluation testing of asymptomatic/atypical patients with PAD. In this Phase II proposal, Specific Aim #1 will test and integrate hardware and software specifications for these 3 factors. In Specific Aim #2, the RFPi Product Development Team will design, engineer, build, test, and validate pre-clinical and clinical prototypes built to ISO 1345 and CRF 820 GMP standards. In Specific Aim #3 the clinical prototypes will be evaluated in the proof-of-concept Clinical Testing Study in PAD (CTS-PAD) at two Vascular Surgery Clinics in the US. The final product from this Phase II proposal will be the engineering design for the 510k FDA Class II submission and for CMS reimbursement studies as outlined in the Commercialization Plan. RFPi, Inc., will bring the MPSVO2-AVI product to healthcare providers to meet this unmet need in PAD care.

抽象的 外周动脉疾病 (PAD) 在美国（估计 > 800 万）及周边国家是一个巨大的医疗负担 全世界（估计 > 2 亿）人口中，超过 24% 的年龄 > 80 岁的人患有 PAD。 PAD 患者无症状，其余患者中高达 40% 的症状不典型。 传统的踝/臂指数（cABI）比值被建立作为初始诊断评估 不幸的是，有症状的患者进行 PAD 评估具有高敏感性和特异性。 当应用于无症状/非典型患者以及使用 cABI 作为治疗方法时，敏感性大幅下降 USPSTF 的建议与心血管疾病相冲突，这一筛查测试极具争议性。 因此，需要一种改进的方法来评估这些指南。 PAD 患者的无症状/非典型亚群是医疗保健领域未满足的需求，解决方案是 重要的优质机会。 STTR 第一阶段 (R43HL133633-01A1) 结果以及提交的 SBIR (R43HL146579- 01，待重新提交），正在推动一种独特的方法来满足这一医疗保健需求。 表明敏感性的下降与由于共同作用导致的终末器官组织的生理变化有关。 SBC RFPi, Inc. 提议整合非侵入性、非接触式收缩血。 压力阈值确定 → ABI 比率（第一阶段）和外周血氧测定 (SBIR)， 进一步集成到 RFPi 的新型成像技术解决方案多光谱生理可视化中 (MSPV)（FDA 于 2018 年 12 月 14 日批准的第一个外形 MPSV 无创（无染料或电离辐射）和 无需患者接触血统并显示血流分布生理学（血管和血流中的血流） 这种 3 因子整合产品称为 MSPVO2-ABI， 将提供提高评估测试灵敏度所需的生理数据增强 无症状/非典型 PAD 患者。 在此第二阶段提案中，具体目标#1将测试并集成这些的硬件和软件规范 在具体目标 #2 中，RFPi 产品开发团队将设计、工程、构建、测试和 验证根据 ISO 1345 和 CRF 820 GMP 标准构建的临床前和临床原型。 临床原型将在 PAD 概念验证临床测试研究 (CTS-PAD) 中进行评估 美国的两个血管外科诊所 该第二阶段提案的最终产品将是工程。 510k FDA II 类提交和 CMS 报销研究的设计，如 RFPi, Inc. 的商业化计划将向医疗保健提供商提供 MPSVO2-AVI 产品来满足这一要求。 PAD 护理中未满足的需求。