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1060亿美元）负担。许多患有急性和稳定性冠状动脉疾病的CAD患者的标准治疗涉及经皮冠状动脉介入治疗和支架植入术。支架植入术后的临床结局与达到足够的最小支架/血管面积直接相关（即，支架完全展开），支架完全贴靠血管壁。大量研究表明，高达85%的冠状动脉支架展开不足，因此需要球囊后扩张以实现适当的支架扩张。尽管进行了后扩张，但仍有高达58%的支架未充分展开。尽管各种因素影响支架展开，但仅血管/支架回缩和球囊扩张不足被证明是导致支架扩张不足的主要因素。球囊扩张不足导致大部分支架展开不足，考虑到体内依赖于固有不准确的制造商离体压力-直径关系，这并不奇怪。在我们的I期资助（R43 HL 120517-冠状动脉后扩张导管）中，描述了一种新型器械，其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）在充盈期间提供实时球囊尺寸。第一阶段研究的结果对这两个目标都非常成功。目标1中更新了显示控制台和CB导管，目标2中CB导管在受损猪冠状动脉血管中的确认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 mm，这在临床上是高度可接受的，因为这至少小一个数量级（即，比0.5mm标准支架分割小10倍）。在本II期申请中，我们建议下一步获得试验用器械豁免（IDE）的批准，以进行人体初步研究，主要用于评估CAD患者组中的器械安全性，其次是器械有效性。为了实现这些II期目标，提出了以下具体目标：1）最终动物确认：在良好实验室规范（GLP）环境中评估CB导管系统在一组患病动物中的安全性和有效性，以用于向FDA和机构审查委员会（IRB）提交数据;和2）人体确认：在一项双中心研究中评估一小组人（30例患者）的安全性和疗效。这项II期研究解决了一个非常重要的国家和世界范围的临床需求，不仅可以影响NHLBI，但NIH的许多其他使命领域。这些目标的成功完成将使我们能够将我们的研究成果转化为可大幅改善CAD患者结局的市售器械。