Non-Invasive Physiologic Evaluation of Peripheral Arterial Disease
周围动脉疾病的无创生理学评估
基本信息
- 批准号:10004703
- 负责人:
- 金额:$ 52.46万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AddressAdultAffectAgeAged, 80 and overAmputationAnatomyAngiographyAnimal TestingAnkleAtherosclerosisAutomobile DrivingBlood PressureBlood VesselsBlood flowCardiovascular DiseasesCardiovascular systemCaringCerebrovascular DisordersCharacteristicsCholesterolClinicClinicalComputer softwareConflict (Psychology)DataData AnalysesDiabetes MellitusDiagnosticDiseaseDyesEngineeringEnrollmentEvaluationFDA approvedGuidelinesHealth PersonnelHealthcareHypertensionImageImaging technologyInstitutional Review BoardsIonizing radiationLower ExtremityMeasurementMetabolismModificationMyocardialMyocardial IschemiaNormal RangeOperative Surgical ProceduresOpticsOrganOxygenPatientsPerfusionPeripheralPeripheral Vascular DiseasesPeripheral arterial diseasePhasePhysiologicalPhysiologyPopulationRecommendationResearchRisk FactorsSensitivity and SpecificitySmall Business Innovation Research GrantSmall Business Technology Transfer ResearchSmokingSocietiesSpecificityStenosisSymptomsTestingTimeTissuesTrainingUniversitiesVisualizationWalkingaging populationbasecare deliveryclaudicationcommercializationcomorbiditydesigndiabeticengineering designevaluation/testingfallsimage visualizationimprovedindexingmedical specialtiesmeetingsnovelnovel imaging technologyperformance testsphantom modelpre-clinicalproduct developmentprototyperesearch clinical testingscreening
项目摘要
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.
摘要
外周动脉疾病(PAD)在美国(估计为800万英镑)及周边地区是一个巨大的医疗负担
全球(估计为2亿英镑)。在老龄化人口中,超过24%的80岁以上的人有PAD。50%的人
患有PAD的患者没有症状,其余患者中高达40%有不典型症状。
传统的踝关节/臂指数(CABI)比率被确立为对
有症状的患者进行PAD评估,具有很高的敏感性和特异性。不幸的是,
当应用于无症状/不典型患者和使用CABI作为
筛查试验极具争议性。USPSTF的建议与心血管疾病相冲突
医学专科学会指南。因此,一个改进的方法来评估这些
PAD患者的无症状/非典型亚群在医疗保健中是一个未得到满足的需求,解决方案是
重要的质量机遇。
STTR第一阶段(R43HL133633-01A1)结果和提交的SBIR的初步数据(R43HL146579-
01,等待重新提交),正在推动一种独特的方法来满足这一医疗需求。最新数据
提示这种敏感度的下降与慢性应激引起的终末器官组织的生理变化有关。
发病率和风险因素。SBC RFPI,Inc.建议将非侵入性、非接触性收缩血液
压力阈值测定ABI比率(阶段I)与外周氧气测定(SBIR),
进一步集成到RFPI的新成像技术解决方案--多光谱生理可视化
(MSPV)(FDA批准的第一外形规格12/14/18)。MPSV无创(无染料或电离辐射)和
无需患者接触即可分析和显示血流分布生理(血管内流动和
组织中的灌注)在目标组织中真正实时地。这款名为MSPVO2-ABI的三要素集成产品,
将提供必要的生理数据增强,以提高在评估测试中的敏感性
无症状/不典型的PAD患者。
在此阶段II提案中,特定目标#1将测试和集成以下各项的硬件和软件规范
3个因素。在具体目标#2中,RFPI产品开发团队将设计、设计、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。在具体目标3中
临床原型将在PAD的概念验证临床测试研究(CTS-PAD)中进行评估
美国的两家血管外科诊所。该第二阶段提案的最终产品将是工程
为510k FDA第二类提交文件和CMS报销研究设计,如
商业化计划。RFPI,Inc.将把MPSVO2-AVI产品带给医疗保健提供商以满足这一要求
垫子护理中未得到满足的需求。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Thomas Bruce Ferguson其他文献
Thomas Bruce Ferguson的其他文献
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{{ truncateString('Thomas Bruce Ferguson', 18)}}的其他基金
Multi-spectral Physiologic Visualization Imaging For Non-contact, Real-time Capture of Cardiovascular Vital Signs Using a Novel Optical Engineering Design
使用新颖的光学工程设计非接触式实时捕获心血管生命体征的多光谱生理可视化成像
- 批准号:
10324829 - 财政年份:2021
- 资助金额:
$ 52.46万 - 项目类别:
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