Catheter for Complex Percutaneous Coronary Intervention

摘要 在美国，每年有近100万例经皮冠状动脉介入治疗(PCI)。大致 其中70%的病例被认为是复杂的，需要治疗严重钙化的病变，曲折 血管和多支血管病变，常伴有完全或半完全闭塞病变。许多运营商避免了这些 更复杂的情况，由于较小的限制，通常不适合径向访问方法 引导导管的大小和缺乏有效输送冠状动脉支架所需的支持。要克服这一点 局限性，引导延长导管(GEC)已经被开发出来，以帮助在这些具有挑战性的情况下输送支架 解剖学。目前，近18%的冠状动脉介入治疗中使用了GEC。然而，GEC已经 几个关键的缺陷使它们不能被用作救助方案。具体来说，当前 在28%的病例中，GEC无法接触到更远端的曲折病变，导致无法提供 支架置入率为56%。钝端管状血管内皮细胞也存在严重的冠状动脉安全问题。 解剖和/或斑块或血栓栓塞术。鉴于在所有的PCI案例中使用GEC的比例为18%，这些 数据表明，有相当数量的患者没有得到有效治疗。因此，CrossLiner Inc. 开发了一种新型多功能GEC，它结合了更深层次的导管插管要求和 球囊微导管引流尖端，允许穿越曲折冠状动脉的严重病变，随后 血管成形术打开病变进行支架植入术。GEC与从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，可以在病变处脱鞘 而不是从支撑性较差的近端位置输送。这种方法是由 CrossLiner GEC可以显著提高复杂病变患者的介入治疗简便性，同时减少 与手术时间、放射/造影剂暴露、支架移位、冠状动脉夹层相关的风险 和穿孔，如当前的GEC所示。初步数据支持CrossLiner的MULTH-LINESS实用程序 通过展示通过90度起飞所需的力量显著减少26%来实现有效的GEC 与市场领先的Guideliner GEC相比，GEC的插管深度增加了68%。这些 这些发现将执行球囊预扩张的时间减少了62%，共同支持 在提高安全性的同时，复杂的经皮冠状动脉介入治疗成功率可能显著提高。The CrossLiner 系统现在已经准备好对性能功能和流程改进进行最终改进，这将是 首先在试验台上进行表征(目标1)，然后是体内安全性和有效性评估(目标2)。成功 这些第一阶段研究的实施将适当地将Crossliner GEC系统定位为全面开发， 临床研究、监管批准(未来第二阶段)，以及这一极具创新性的新产品的商业化 以及可能改变游戏规则的方法，以提高复杂的经皮冠状动脉介入治疗患者的护理标准。

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.