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主要的临床（约1600万）和财务（约106B $ 106B）。许多患有急性和稳定冠状动脉疾病的CAD患者的护理标准涉及带有支架的经皮冠状动脉干预。支架后的临床结局与具有完全支架对血管壁的完全支架置脚的足够最小支架/血管区域（即完全支架部署）直接相关。大量研究表明，所有冠状动脉支架中有多达85％的固定杆不足，因此需要稀释后的气球才能实现适当的支架膨胀。尽管稀释后，多达58％的支架仍然不足。尽管各种因素会影响支架部署，但仅血管/支架后坐力和膨胀气球不足是导致支架不足的主要因素。气球不足的膨胀造成了大多数支架的部署，这并不奇怪，鉴于体内依赖固有的不准确的制造商的离体压力直径直径的关系。在我们的第一阶段赠款（R43 HL120517-冠状后导管）中，描述了一种新型装置，该设备是作为标准冠状动脉后导管的标准装置，但在膨胀期间基于欧姆定律而不是经验压力直径的关系，也提供实时气球尺寸。 I阶段研究的结果对于这两个目标都非常成功。在AIM＃1中对显示控制台和CB导管进行了更新，并且在AIM＃2中对受伤的猪冠状动脉血管中的CB导管的验证非常准确（即，在Vivo CB CB气球测量精度偏差= 0.05mm，临床上是非常可接受的，这至少比标准级要小（I.E.E.E.E.E.E.E.E.E.E.E.E.E.E.E.E.E）。在此II阶段的应用中，我们提出了下一步获得研究设备豁免（IDE）的批准，以进行人类试点研究，该研究将用于评估设备安全性，其次是一组CAD患者的设备功效。为了实现这些II期目标，提出了以下具体目的：1）最终动物验证：评估在一组患病动物中，在一组良好实践（GLP）设置中，CB导管系统的安全性和有效性用于数据提交FDA和FDA和机构审查委员会（IRB）； 2）人类验证：在一项两点研究中，评估一小群人（30名患者）的安全性和功效。这项第二阶段的研究解决了一项非常重要的国家和全球临床需求，不仅会影响NHLBI，而且会影响NIH的许多其他任务领域。这些提出的目标的成功完成将使我们能够将研究结果转化为可大大改善CAD患者结果的市售设备。