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，需要治疗钙化病变、血管扭曲、 多支血管病变，常伴有完全或半完全闭塞病变。许多运营商更多地避免了这些 复杂的情况，由于尺寸较小的限制，通常不适合径向进入方法 引导导管和缺乏有效输送冠状动脉支架和其他介入性支架所需的支持 设备。为了克服这一限制，人们开发了引导延长导管(GEC)来帮助 在这些具有挑战性的解剖结构中植入支架。目前约有18%的冠脉病变患者使用了GEC 干预措施。然而，GEC有几个关键的缺点，这些缺点阻碍了它们的使用，而不是作为 救市选项。具体地说，目前的GEC在28%的病例中无法接触到更远端的曲折病变， 导致在许多情况下不能输送支架。钝端管状GEC也有严重的安全性 冠状动脉夹层和/或斑块或血栓栓塞术的问题。鉴于GEC用于 ~18%的冠状动脉介入治疗病例中，这些数据代表了大量未得到有效治疗的患者。 为此，CrossLiner Inc.开发了一种新型多功能GEC，它结合了对更深层次的需求 导管插管具有微导管前导尖端，并在前导元件上预扩张气囊，以允许 曲折冠状动脉严重病变的安全穿越，先用球囊预扩张，然后再穿越 将病变与导引延长，然后无缝支架置入。GEC与 从外部到内部的无缝过渡-微导管球囊提供了更容易放置支架的能力 分娩，可以在病变处脱鞘，而不是从支撑不良的 最近的位置。CrossLiner GEC支持的这种方法将显著改善患有以下疾病的患者的PCI 同时降低风险、手术持续时间、放射/造影剂暴露、支架移位、 当前GEC存在的冠状动脉夹层和穿孔。来自BASE和活体I期研究的数据 通过显著降低作用力来支持CrossLiner的多功能GEC的效用 与第一代相比，需要通过高度倾斜的管段，同时增加插管深度 设备。结果体内插管深度从5.6 cm增加到12.9 cm，插管深度减少41%。 是时候植入支架了。重要的是，CrossLiner GEC能够成功地跨越支架节段 在猪复杂病变模型中的所有血管，而第一代设备被卡在支架近端 或在支架边缘的~75%的冠状动脉被检测。CrossLiner系统现在已经准备好进行决赛 流程改进和设计控制开发(目标1)，随后是可用性评估和监管 净空(目标2)。这些第二阶段研究的成功实施将使CrossLiner GEC系统 将这一高度创新的方法全面商业化，以改善复杂冠状动脉介入治疗患者的治疗。

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 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 and other interventional devices. To overcome this limitation, guide extension catheters (GEC) have been developed to help deliver stents in these challenging anatomies. GECs are currently utilized in approximately 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 many cases. 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 microcatheter leading tip, and pre-dilatation balloon on the leading element, to allow safe crossing of severe lesions in tortuous coronary vessels, with balloon pre-dilatation, followed by crossing the lesion with the guide extension and then seamless stent delivery. The combination of a GEC with a seamless transition from the outer to the inner microcatheter-balloon provides the capability for easier stent delivery, which can be unsheathed at the lesion as opposed to being delivered from a poorly supported proximal location. This approach enabled by the CrossLiner GEC will substantially improve PCI in patients with complex lesions while reducing risks, procedural duration, radiation/contrast exposure, stent dislodgement, coronary dissection and perforation that exist with current GECs. Data from bench and in vivo Phase I studies support the utility of CrossLiner’s multi-functional GEC by demonstrating a significant reduction in the force required to pass a highly angulated segment while increasing the intubation depth compared to first-generation devices. Results in vivo showed an increase in intubation depth from 5.6 cm to 12.9 cm and a 41% reduction in the time to deliver a stent. Importantly, the CrossLiner GEC was able to successfully cross stented segments in all vessels in a swine model of complex lesions, while first-generation devices were stuck proximal to the stent or at the stent edge in ~75% of the coronary vessels tested. The CrossLiner system is now ready for final process refinement and design control development (Aim 1) followed by usability evaluation, and regulatory clearance (Aim 2). Successful execution of these Phase II studies will position the CrossLiner GEC system for full commercialization of this highly innovative approach to improve the treatment for complex PCI patients.