Catheter for Complex Percutaneous Coronary Intervention

摘要 美国每年进行近100万例经皮冠状动脉介入治疗（PCI）。约 这些病例中有70%被认为是复杂的，需要治疗钙化病变、迂曲血管， 和多血管疾病，通常具有完全或次完全闭塞的病变。许多运营商避免这些更多 复杂病例，由于尺寸较小，通常不适合桡动脉入路 导引导管和缺乏有效输送冠状动脉支架和其他介入治疗所需的支持 装置.为了克服这一限制，已经开发了引导延伸导管（GEC）以帮助递送 这些具有挑战性的解剖结构中的支架。GEC目前用于约18%的所有冠状动脉 干预措施。然而，GEC有几个关键的缺点，这些缺点阻止了它们的使用，而不是作为一种 救助选项具体而言，在28%的病例中，目前的GEC无法进入更远端的迂曲病变， 导致在许多情况下不能输送支架。钝端管状GEC也具有严重的安全性 冠状动脉夹层和/或斑块或血栓栓塞问题。鉴于GEC用于 在所有PCI病例中约18%，这些数据代表了大量未得到有效治疗的患者。 因此，CrossLiner Inc.开发了一种新型的多功能GEC，结合了更深层次的需求， 使用微导管引导头端和引导元件上的预扩张球囊进行导管插管， 安全通过迂曲冠状血管中的严重病变，球囊预扩张，然后通过 使用导引延长管插入病变，然后进行无缝支架输送。GEC与 从外部到内部微导管-球囊的无缝过渡提供了更容易支架的能力 输送，可以在病变处拔出鞘管，而不是从支撑不良的 近端位置。通过CrossLiner GEC实现的这种方法将显著改善以下患者的PCI： 复杂病变，同时降低风险、手术持续时间、辐射/造影剂暴露、支架脱位， 冠状动脉夹层和穿孔。实验室和体内I期研究的数据 支持CrossLiner的多功能GEC的效用，通过证明力的显着减少 与第一代相比，需要通过高度成角的节段，同时增加插管深度 装置.体内结果显示插管深度从5.6 cm增加到12.9 cm， 植入支架的时间重要的是，CrossLiner GEC能够成功穿过植入支架的节段， 复杂病变猪模型中的所有血管，而第一代器械卡在支架近端 或在约75%的受试冠状动脉血管的支架边缘。CrossLiner系统现已准备就绪， 过程改进和设计控制开发（目标1），然后是可用性评估和监管 清除率（目标2）。这些II期研究的成功执行将使CrossLiner GEC系统定位于 这一高度创新的方法的全面商业化，以改善复杂PCI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.