Enabling rapid and effective stroke thrombectomy procedures from a Transradial approach: Combining introducer sheath, guide catheter, and distal access catheter into a single device.

项目总结/摘要 该提案将改善急性缺血性卒中（AIS）患者的护理。基于导管 血栓切除术已被确定为AIS的标准治疗方法。但仍有很大的限制：<50% 的患者实现首过血凝块清除，这是良好神经结局的最佳预测因素，主要原因是 方法（经股动脉入路[TFA]）和当前用于抽吸凝块的导管的缺点。 考虑到许多或大多数血栓切除术候选者的高龄， 当从股动脉到颈动脉区域穿越时遇到。事实表明， 迂曲导致TFA手术的结局更差。因此，许多主要的干预主义者提出， 经桡动脉入路（TRA）代替经股动脉入路。TRA已经是广大 由于出血并发症的发生率低， 冠状动脉循环桡动脉部位也提供了进入脑血管的通路， 沿着主动脉弓、降主动脉和髂股系统的迂曲。然而，神经介入医生 使用TRA的患者使用股骨导引鞘（如Ballast或Neuron Max）， 设计用于径向至颅内导航，由于血管痉挛或 桡动脉闭塞可能是由于他们对TRA的不完全适应。 神经介入治疗的平行进步是SuperBore远端通路导管（DAC），用于 有效地从患有AIS的患者的动脉中取出凝块。这些SuperBore DAC提供大容量 流明（与传统DAC相比，吸力增加>30%），但在 迂曲的解剖结构，近一半的手术导致无法导航到凝块面。虽然他们 提供了DAC尺寸的重大进步，由于以下原因，TRA方法未考虑SuperBores 它们的厚壁和硬头端，妨碍了实现最佳导航或抽吸功率的能力， 径向入路我们的团队在美敦力收购我们的 通过对50多名医生的密集采访，获得了之前SBIR资助的项目。 在我们成功的第一阶段项目中，我们开发并测试了新型SuperBore血栓切除系统 适合TRA。具体而言，我们的“腕-脑”血栓切除系统提供了独特的优势， （1）将导引导管和SuperBore DAC结合在一根导管中，（2）我们的 新型专利内衬，以及（3）高度可跟踪和抗扭结的轴，仍然适合桡动脉内， 大多数病人在第二阶段SBIR计划中，我们提出了一个由FDA指导的完整的正式验证计划。 试验标准（目标1），然后是广泛的实验室、GLP动物和尸体试验（目标2）。这笔赠款 将使我们能够完成提交FDA批准所需的所有测试，并开始销售我们的新产品， 有效的腕-脑血栓切除系统，以改善LVO AIS患者的护理。

PROJECT SUMMARY/ABSTRACT This proposal will improve the care of patients suffering from Acute Ischemic stroke (AIS). Catheter-based thrombectomy has been established as the standard treatment for AIS. Still, substantial limitations remain: <50% of patients achieve first-pass clot clearance, the best predictor of good neurological outcome, largely due to shortcomings in the approach (transfemoral access [TFA]) and the current catheters used to aspirate clots. Given the advanced age of many or most thrombectomy candidates, highly tortuous vessels are frequently encountered when traversing from the femoral to carotid territories. It has been shown that substantial tortuosity leads to worse outcomes in TFA procedures. Thus, many leading interventionalists have proposed transradial access (TRA) in place of transfemoral access. TRA is already the preferred access site for the vast majority of interventional cardiology procedures, given low rates of bleeding complications and ready access to the coronary circulation. The radial site also provides ready access to the cerebral vasculature, bypassing tortuosity along the aortic arch, descending aorta, and ilio-femoral system. However, neurointerventionalists who use TRA are stuck employing femoral guide sheaths (such as the Ballast or Neuron Max), which are not designed for the radial-to-intracranial navigation and which have safety concerns due to the vasospasm or radial artery occlusion that can result from their imperfect adaptation to TRA. A parallel advancement in neurointervention is that of SuperBore Distal Access Catheters (DACs) used to efficiently pull out clots from arteries of patients suffering from AIS. These SuperBore DACs provide large lumens (increasing suction by >30% over conventional DACs), but struggle with navigation challenges in tortuous anatomies, with nearly half of procedures resulting in failure to navigate to the clot face. While they provide a major advance in DAC sizing, SuperBores have not been considered for TRA approaches due to their thick walls and stiff tips, precluding the ability to achieve optimized navigation or suction power from the radial approach. Our team discovered this pressing need after achieving acquisition by Medtronic of our previous SBIR-funded program via intensive interviews of 50+ physicians. In our successful Phase I project, we developed and tested our novel SuperBore thrombectomy system appropriate for TRA. Specifically, our “Wrist-to-Brain” thrombectomy system provides the distinct advantages of: (1) combining guide catheter and SuperBore DAC in a single catheter, (2) hyperthin walls enabled by our novel, proprietary liner, and (3) a highly trackable and kink resistant shaft that still fits within the radial artery in most patients. In this Phase II SBIR program, we propose a full, formal validation program guided by FDA testing criteria (Aim 1), followed by extensive benchtop, GLP animal, and cadaveric testing (Aim 2). This grant will enable us to complete all testing needed to submit for FDA clearance and begin marketing our novel and impactful Wrist-to-Brain thrombectomy system in order to improve the care of patients suffering from LVO AIS.