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Catheter for Complex Percutaneous Coronary Intervention

用于复杂经皮冠状动脉介入治疗的导管

基本信息

批准号：
10081005
负责人：
Tim Alexander Fischell
金额：
$ 29.82万
依托单位：
CROSSLINER INC
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-07-20 至 2021-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10081005
关键词：
Acute Address Affect American Anatomy Angioplasty Arteries Catheters Characteristics Child Clinical Research Complex Complication Coronary Coronary Arteriosclerosis Coronary Vessels Coronary artery Data Development Dilatation - action Disease Dissection Distal Failure Family suidae Financial Hardship Flare Foundations Future Goals Guidelines Healthcare Systems Institutes Intervention Intubation Lead Length Lesion Location Modeling Mothers National Heart, Lung, and Blood Institute Pacemakers Patients Perforation Performance Peripheral Phase Positioning Attribute Probability Procedures Process Radial Radiation Risk Running Safety Site Stents System Technology Therapeutic Embolization Thrombus Time TimeLine Translating Tube Tubular formation United States National Institutes of Health Venous calcification commercialization cost effective therapy improved in vivo innovation man mortality novel patient population patient safety percutaneous coronary intervention phase 1 study prevent safety assessment standard of care success tool

项目摘要

ABSTRACT Nearly 1 million percutaneous coronary interventions (PCIs) are performed each year in the US. Approximately 70% of these cases are considered complex and require the treatment of heavily calcified lesions, tortuous vessels, and multi-vessel disease, often with total or sub-totally occluded lesions. Many operators avoid these more complex cases, which are often not suitable for radial access approaches due to the limitations of smaller size guide catheters and lack of support required to effectively deliver coronary stents. To overcome this limitation, guide extension catheters (GEC) have been developed to help deliver stents in these challenging anatomies. GECs are currently utilized in nearly 18% of all coronary interventions. However, GECs have several key shortcomings that have prevented their usage other than as a bailout option. Specifically, current GECs are unable to access more distal tortuous lesions in 28% of cases resulting in the inability to deliver a stent in 56% of attempts. Blunt ended tubular GECs also have serious safety issues with coronary artery dissection and/or plaque or thrombus embolization. Given that GECs are used in 18% of all PCI cases, these data represent a significant volume of patients that are not treated effectively. Hence, CrossLiner Inc. has developed a novel multi-functional GEC that combines the requirement for deeper catheter intubation with a balloon microcatheter leading tip to allow crossing severe lesions in tortuous coronary vessels, followed by angioplasty to open the lesion for stenting. The combination of a GEC with a seamless transition from the outer to the inner microcatheter provides the capability for easier stent delivery which can unsheathed at the lesion as opposed to being delivered from a poorly supported proximal location. This approach enabled by the CrossLiner GEC could substantially enhance the ease of PCI in patients with complex lesions while reducing risks associated with procedural duration, radiation/contrast exposure, stent dislodgement, coronary dissection and perforation as shown with current GECs. Preliminary data support the utility of CrossLiner’s multi- functional GEC by demonstrating a significant 26% reduction in the force required to pass a 90 degree takeoff angulation and a 68% increase in intubation depth compared to the market leading GuideLiner GEC. These findings translated to a 62% reduction in the time to perform balloon pre-dilation and collectively support a likely significant increase in complex PCI success rates while simultaneously improving safety. The CrossLiner system is now ready for final refinement of performance features and process improvements which will be characterized first on bench (Aim 1) followed by in vivo assessment of safety and efficacy (Aim 2). Successful execution of these Phase I studies will appropriately position the Crossliner GEC system for full development, clinical studies, regulatory approval (future Phase II), and commercialization of this novel, highly innovative, and potentially “game-changing” approach to improve the standard of care for complex PCI patients.

抽象的美国每年进行近 100 万例经皮冠状动脉介入治疗 (PCI)。大约其中70%的病例被认为是复杂的，需要治疗严重钙化的病灶、曲折的病灶血管和多血管疾病，通常伴有完全或部分完全闭塞的病变。许多运营商都回避这些更复杂的情况，由于较小的限制，通常不适合径向进入方法尺寸引导导管和缺乏有效输送冠状动脉支架所需的支撑。为了克服这个为了克服这些限制，我们开发了引导延伸导管 (GEC)，以帮助在这些具有挑战性的情况下输送支架解剖学。目前，GEC 应用于近 18% 的冠状动脉介入治疗中。然而，GEC 有一些关键的缺点阻碍了它们除了作为救助选项之外的使用。具体来说，当前 28% 的病例中，GEC 无法到达更远端的迂曲病变，导致无法提供治疗 56% 的尝试中使用了支架。钝端管状 GEC 对冠状动脉也存在严重的安全问题夹层和/或斑块或血栓栓塞。鉴于 18% 的 PCI 病例使用了 GEC，这些数据代表大量未得到有效治疗的患者。因此，CrossLiner Inc. 开发了一种新型多功能 GEC，它将更深的导管插管的要求与球囊微导管引导尖端允许穿过曲折冠状血管中的严重病变，然后血管成形术打开病变部位进行支架植入。 GEC 与外部无缝过渡的结合到内部微导管提供了更容易的支架输送能力，可以在病变处拔出护套与从支撑不良的近端位置输送相反。这种方法由 CrossLiner GEC 可以显着提高复杂病变患者 PCI 的简易性，同时减少与手术持续时间、辐射/造影剂暴露、支架移位、冠状动脉夹层相关的风险和穿孔，如当前 GEC 所示。初步数据支持 CrossLiner 的多用途功能性 GEC 证明通过 90 度起飞所需的力显着减少 26% 与市场领先的 GuideLiner GEC 相比，角度和插管深度增加了 68%。这些研究结果意味着执行球囊预扩张的时间减少了 62%，并共同支持了可能会显着提高复杂 PCI 的成功率，同时提高安全性。十字线系统现已准备好进行性能特征和流程改进的最终细化，这将是首先在实验室进行表征（目标 1），然后进行体内安全性和有效性评估（目标 2）。成功的这些第一阶段研究的执行将为 Crossliner GEC 系统的全面开发提供适当的定位，这种新颖的、高度创新的、以及潜在的“改变游戏规则”的方法，以提高复杂 PCI 患者的护理标准。