Coronary Post-Dilatation Catheter

冠状动脉后扩张导管

• 批准号: 9084610
• 负责人: William Combs
• 金额: $ 78.14万
• 依托单位: 3DT HOLDINGS, LLC
• 依托单位国家: 美国
• 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: https://reporter.nih.gov/project-details/9084610
• 关键词: Achievement; Acute; Address; Affect; American; Animal Model; Animals; Area; Award; Balloon Dilatation; Beds; Blood Vessels; Cadaver; Caliber; Catheters; Chronic; Clinical; Coronary; Coronary Arteriosclerosis; Coronary Vessels; Coronary artery; Data; Data Collection; Development; Device Safety; Devices; Dilatation - action; Dimensions; Drops; Economic Inflation; Electrodes; Family suidae; Feasibility Studies; Health; Healthcare Systems; Human; Image; In Vitro; Incidence; Institutes; Institutional Review Boards; Laws; Length; Manufacturer Name; Measurement; Measures; Metals; Mission; National Heart, Lung, and Blood Institute; National Institute of Diabetes and Digestive and Kidney Diseases; National Institute of Neurological Disorders and Stroke; Outcome; Patient-Focused Outcomes; Patients; Pharmaceutical Preparations; Phase; Pilot Projects; Positioning Attribute; Preparation; Procedures; Property; Publications; R43 grant; Recommendation; Research; Safety; Side; Small Business Innovation Research Grant; Stents; System; Technology; Therapeutic; Time; Translating; United States National Institutes of Health; Update; Validation; base; clinical practice; commercialization; cost; good laboratory practice; human data; improved; in vivo; injured; man; meetings; mortality; novel; percutaneous coronary intervention; phase 1 study; phase 2 study; pressure; restenosis; standard of care; success; voltage

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。