Coronary Post-Dilatation Catheter
冠状动脉后扩张导管
基本信息
- 批准号:9084610
- 负责人:
- 金额:$ 78.14万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2013
- 资助国家:美国
- 起止时间:2013-09-01 至 2020-05-31
- 项目状态:已结题
- 来源:
- 关键词:AchievementAcuteAddressAffectAmericanAnimal ModelAnimalsAreaAwardBalloon DilatationBedsBlood VesselsCadaverCaliberCathetersChronicClinicalCoronaryCoronary ArteriosclerosisCoronary VesselsCoronary arteryDataData CollectionDevelopmentDevice SafetyDevicesDilatation - actionDimensionsDropsEconomic InflationElectrodesFamily suidaeFeasibility StudiesHealthHealthcare SystemsHumanImageIn VitroIncidenceInstitutesInstitutional Review BoardsLawsLengthManufacturer NameMeasurementMeasuresMetalsMissionNational Heart, Lung, and Blood InstituteNational Institute of Diabetes and Digestive and Kidney DiseasesNational Institute of Neurological Disorders and StrokeOutcomePatient-Focused OutcomesPatientsPharmaceutical PreparationsPhasePilot ProjectsPositioning AttributePreparationProceduresPropertyPublicationsR43 grantRecommendationResearchSafetySideSmall Business Innovation Research GrantStentsSystemTechnologyTherapeuticTimeTranslatingUnited States National Institutes of HealthUpdateValidationbaseclinical practicecommercializationcostgood laboratory practicehuman dataimprovedin vivoinjuredmanmeetingsmortalitynovelpercutaneous coronary interventionphase 1 studyphase 2 studypressurerestenosisstandard of caresuccessvoltage
项目摘要
DESCRIPTION (provided by applicant): Coronary artery disease (CAD) places a major clinical (~16M) and financial (~$106B by 2030) burden on the U.S. healthcare system. The standard of care for many CAD patients with acute and stable coronary conditions involves percutaneous coronary intervention with stenting. Clinical outcomes following stenting are directly related to the achievement of adequate minimal stent/vascular area (i.e., full stent deployment) with full stent apposition against the vascular wall. Numerous studies have shown that up to 85% of all coronary stents are under-deployed and therefore require balloon post-dilatation to achieve proper stent expansion. Despite post-dilatation, up to 58% of stents still remain under-deployed. Although various factors affect stent deployment, only vascular/stent recoil and balloon under-expansion were shown to be the major factors causing stent under-expansion. Balloon under-expansion contributes to the majority of the stent under- deployment, which is not surprising given the in vivo reliance on inherently inaccurate manufacturer ex vivo pressure-diameter relationships. In our Phase I grant (R43 HL120517 - Coronary Post-Dilatation Catheter), a novel device was described which operates as a standard coronary post-dilatation catheter, but also provides real-time balloon dimension during inflation based on Ohm's law instead of empirical pressure-diameter relationships. The results of the Phase I study were extremely successful for both aims. The display console and CB catheter were updated in Aim #1 and validation of the CB catheter in injured swine coronary vessels showed extremely accurate post-dilatation in Aim #2 (i.e., in vivo CB balloon measurement accuracy bias = 0.05mm, which is highly acceptable clinically given this is at least an order of magnitude smaller (i.e., 10x smaller) than the 0.5mm standard stent divisions). In this Phase II application, we propose the next step of obtaining approval for an investigational device exemption (IDE) to conduct a human pilot study which will be used to assess primarily the device safety and secondarily device efficacy in a group of CAD patients. To accomplish these Phase II objectives, the following specific aims are proposed: 1) Final Animal Validation: To assess the safety and efficacy of the CB catheter system in a set of diseased animals in a good-laboratory practice (GLP) setting to be used for data submission to the FDA and institutional review boards (IRBs); and 2) Human Validation: To assess the safety and efficacy in a small group of humans (30 patients) in a two-center study. This Phase II study addresses a highly significant national and worldwide clinical need that can impact not just NHLBI, but many other mission areas of NIH. Successful completion of these proposed Aims will allow us to translate our research findings to a commercially available device that could drastically improve CAD patient outcomes.
描述(由申请人提供):冠状动脉疾病 (CAD) 给美国医疗保健系统带来了重大的临床(约 1600 万)和财务(到 2030 年约 106B 美元)负担。许多患有急性和稳定冠状动脉疾病的 CAD 患者的护理标准包括经皮冠状动脉介入治疗和支架置入术。支架置入后的临床结果与实现足够的最小支架/血管面积(即支架完全展开)以及支架完全贴靠在血管壁上直接相关。大量研究表明,高达 85% 的冠状动脉支架未充分展开,因此需要球囊后扩张以实现支架的适当扩张。尽管进行了扩张后,高达 58% 的支架仍然未充分展开。尽管影响支架展开的因素有多种,但只有血管/支架反冲和球囊扩张不足是导致支架扩张不足的主要因素。球囊膨胀不足是支架展开不足的主要原因,考虑到体内依赖于本质上不准确的制造商体外压力-直径关系,这并不奇怪。在我们的第一阶段资助(R43 HL120517 - 冠状动脉后扩张导管)中,描述了一种新颖的装置,它作为标准冠状动脉后扩张导管运行,但也根据欧姆定律而不是经验压力直径关系在膨胀过程中提供实时球囊尺寸。第一阶段研究的结果对于这两个目标都非常成功。显示控制台和 CB 导管在目标 #1 中进行了更新,并且在目标 #2 中对受伤猪冠状血管中的 CB 导管进行了验证,显示出极其准确的后扩张(即体内 CB 球囊测量精度偏差 = 0.05 毫米,这在临床上是高度可接受的,因为这比 0.5 毫米标准支架间距至少小一个数量级(即小 10 倍)。在此 II 期申请中,我们建议下一步获得研究性器械豁免 (IDE) 的批准,以进行人体试点研究,该研究将主要用于评估一组 CAD 患者的器械安全性,其次评估器械功效。为了实现这些 II 期目标,提出了以下具体目标: 1) 最终动物验证:在良好实验室规范 (GLP) 环境下评估 CB 导管系统在一组患病动物中的安全性和有效性,用于向 FDA 和机构审查委员会 (IRB) 提交数据; 2) 人体验证:在两中心研究中评估一小群人类(30 名患者)的安全性和有效性。这项 II 期研究解决了非常重要的国家和全球临床需求,不仅会影响 NHLBI,还会影响 NIH 的许多其他任务领域。成功完成这些拟议目标将使我们能够将研究成果转化为商用设备,从而大大改善 CAD 患者的治疗效果。
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)
数据更新时间:{{ journalArticles.updateTime }}
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
数据更新时间:{{ journalArticles.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ monograph.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ sciAawards.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ conferencePapers.updateTime }}
{{ item.title }}
- 作者:
{{ item.author }}
数据更新时间:{{ patent.updateTime }}
William Combs其他文献
William Combs的其他文献
{{
item.title }}
{{ item.translation_title }}
- DOI:
{{ item.doi }} - 发表时间:
{{ item.publish_year }} - 期刊:
- 影响因子:{{ item.factor }}
- 作者:
{{ item.authors }} - 通讯作者:
{{ item.author }}
{{ truncateString('William Combs', 18)}}的其他基金
Biomechatronics Device for Diagnosis/Therapy of Anorectal Disorders
用于诊断/治疗肛门直肠疾病的生物机电一体化设备
- 批准号:
10404789 - 财政年份:2021
- 资助金额:
$ 78.14万 - 项目类别:
Biomechatronics Device for Diagnosis/Therapy of Anorectal Disorders
用于诊断/治疗肛门直肠疾病的生物机电一体化设备
- 批准号:
10256222 - 财政年份:2021
- 资助金额:
$ 78.14万 - 项目类别:
Biomechatronics Device for Diagnosis/Therapy of Anorectal Disorders
用于诊断/治疗肛门直肠疾病的生物机电一体化设备
- 批准号:
10551849 - 财政年份:2021
- 资助金额:
$ 78.14万 - 项目类别:
Universal amplifier system for high-fidelity multi-modal biosignal recordings
用于高保真多模态生物信号记录的通用放大器系统
- 批准号:
8991528 - 财政年份:2014
- 资助金额:
$ 78.14万 - 项目类别:
Universal amplifier system for high-fidelity multi-modal biosignal recordings
用于高保真多模态生物信号记录的通用放大器系统
- 批准号:
8779659 - 财政年份:2014
- 资助金额:
$ 78.14万 - 项目类别:
Multi-Functional Guidewire for Peripheral Vasculature
外周血管多功能导丝
- 批准号:
8454284 - 财政年份:2013
- 资助金额:
$ 78.14万 - 项目类别:
相似海外基金
Acute senescence: a novel host defence counteracting typhoidal Salmonella
急性衰老:对抗伤寒沙门氏菌的新型宿主防御
- 批准号:
MR/X02329X/1 - 财政年份:2024
- 资助金额:
$ 78.14万 - 项目类别:
Fellowship
Transcriptional assessment of haematopoietic differentiation to risk-stratify acute lymphoblastic leukaemia
造血分化的转录评估对急性淋巴细胞白血病的风险分层
- 批准号:
MR/Y009568/1 - 财政年份:2024
- 资助金额:
$ 78.14万 - 项目类别:
Fellowship
Combining two unique AI platforms for the discovery of novel genetic therapeutic targets & preclinical validation of synthetic biomolecules to treat Acute myeloid leukaemia (AML).
结合两个独特的人工智能平台来发现新的基因治疗靶点
- 批准号:
10090332 - 财政年份:2024
- 资助金额:
$ 78.14万 - 项目类别:
Collaborative R&D
Cellular Neuroinflammation in Acute Brain Injury
急性脑损伤中的细胞神经炎症
- 批准号:
MR/X021882/1 - 财政年份:2024
- 资助金额:
$ 78.14万 - 项目类别:
Research Grant
STTR Phase I: Non-invasive focused ultrasound treatment to modulate the immune system for acute and chronic kidney rejection
STTR 第一期:非侵入性聚焦超声治疗调节免疫系统以治疗急性和慢性肾排斥
- 批准号:
2312694 - 财政年份:2024
- 资助金额:
$ 78.14万 - 项目类别:
Standard Grant
Combining Mechanistic Modelling with Machine Learning for Diagnosis of Acute Respiratory Distress Syndrome
机械建模与机器学习相结合诊断急性呼吸窘迫综合征
- 批准号:
EP/Y003527/1 - 财政年份:2024
- 资助金额:
$ 78.14万 - 项目类别:
Research Grant
FITEAML: Functional Interrogation of Transposable Elements in Acute Myeloid Leukaemia
FITEAML:急性髓系白血病转座元件的功能研究
- 批准号:
EP/Y030338/1 - 财政年份:2024
- 资助金额:
$ 78.14万 - 项目类别:
Research Grant
KAT2A PROTACs targetting the differentiation of blasts and leukemic stem cells for the treatment of Acute Myeloid Leukaemia
KAT2A PROTAC 靶向原始细胞和白血病干细胞的分化,用于治疗急性髓系白血病
- 批准号:
MR/X029557/1 - 财政年份:2024
- 资助金额:
$ 78.14万 - 项目类别:
Research Grant
ロボット支援肝切除術は真に低侵襲なのか?acute phaseに着目して
机器人辅助肝切除术真的是微创吗?
- 批准号:
24K19395 - 财政年份:2024
- 资助金额:
$ 78.14万 - 项目类别:
Grant-in-Aid for Early-Career Scientists
Collaborative Research: Changes and Impact of Right Ventricle Viscoelasticity Under Acute Stress and Chronic Pulmonary Hypertension
合作研究:急性应激和慢性肺动脉高压下右心室粘弹性的变化和影响
- 批准号:
2244994 - 财政年份:2023
- 资助金额:
$ 78.14万 - 项目类别:
Standard Grant