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

通过经桡动脉途径实现快速有效的中风血栓切除术：将导引鞘、引导导管和远端通路导管组合成单个设备。

• 批准号: 10761331
• 负责人: Jared Hutar
• 金额: $ 99.27万
• 依托单位: PIRAEUS MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-29 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10761331
• 关键词: Acute; Address; Adoption; Anatomy; Animal Testing; Animals; Area; Arteries; Automobile Driving; Blood Vessels; Blood coagulation; Brain; Bypass; Cadaver; Cardiology; Catheters; Cause of Death; Cerebrovascular system; Characteristics; Circulation; Clinical; Coagulation Process; Coronary; Coronary Circulation; Data; Descending aorta; Device Designs; Devices; Diameter; Dilator; Distal; Effectiveness; Elderly; Endothelium; Evolution; Extravasation; Face; Failure; Family suidae; Femur; Funding; Future; Goals; Grant; Hematoma; Hemorrhage; In Vitro; Inguinal region; Injections; International; Intervention; Interview; Ischemic Stroke; Leadership; Length; Location; Marketing; Mechanics; Medical; Modernization; Neurological outcome; Neurons; Outcome; Patient Care; Patient-Focused Outcomes; Patients; Performance; Perfusion; Phase; Physicians; Preclinical Testing; Procedures; Radial; Resistance; Risk; Role; Route; Rupture; Safety; Sales; Site; Small Business Innovation Research Grant; Speed; Stents; Stroke; Suction; System; Testing; Thick; Thinness; Thrombectomy; Torque; Vacuum; Validation; Vascularization; Vasospasm; Woman; Work; Wrist; aortic arch; arterial tortuosity; artery occlusion; aspirate; commercialization; design verification; disability; experience; femoral artery; improved; improved outcome; in vitro testing; in vivo; innovation; men; novel; older patient; programs; radial artery; randomized trial; standard care; stroke patient; success; usability; vascular bed

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.

项目摘要/摘要 该建议将改善患有急性缺血性中风（AIS）的患者的护理。基于导管 血栓切除术已成为AIS的标准治疗方法。尽管如此，仍然存在重大限制：<50％ 患者达到了第一越过阻滞清除率，这是良好神经系统结果的最佳预测指标，主要是由于 该方法中的缺点（转际访问[TFA]）和用于吸入布的当前导管。 鉴于许多或大多数候选血栓切除术的高龄，高度曲折的容器经常是 从股骨到颈动脉领土穿越时遇到。已经证明了很大的 曲折性导致TFA程序的结果差。这是许多领先的干预主义者提出的 跨性别访问（TRA）代替经际传输访问。 TRA已经是新的首选访问网站 大多数介入心脏病学程序，鉴于出血并发症的率低，并且可以使用 冠状动脉圈。径向站点还可以随时访问大脑脉管系统，绕过 主动脉弓，降级主动脉和ILIO-FEARAL系统沿线曲折。但是，神经介入主义者 使用TRA的人使用女性指南护套（例如压载或神经元最大），而不是 专为径向到横向导航而设计，并且由于血管痉挛或 径向动脉阻塞可能是由于其不完全适应Tra而导致的。 神经干预的平行进步是超级孔远端通道导管（DAC） 有效地从患有AIS的患者的动脉中拉出人群。这些超级DAC提供了大型 流明（使传统DAC的任务增加> 30％），但与导航挑战斗争 曲折的解剖学，几乎一半的过程导致未能导航到凝块面。当他们 在DAC尺寸方面提供了重大进步，由于 它们的厚墙和僵硬的尖端，排除了从 径向方法。我们的团队在获得Medtronic的收购后发现了这种紧迫的需求 先前通过50多名医生进行的密集采访了SBIR资助的计划。 在我们成功的I阶段项目中，我们开发并测试了我们的新型Super Bore血栓切除术系统 适合Tra。具体而言，我们的“腕部到脑”血栓切除术系统提供了独特的优势 ：（1）将导管导管和超级DAC组合在单个导管中，（2）我们的超细墙由我们 新颖的，专有的衬里和（3）一个高度可追踪和扭结的轴，仍然适合径向动脉 大多数患者。在此II阶段SBIR计划中，我们提出了一个由FDA指导的完整，正式验证计划 测试标准（AIM 1），然后进行广泛的台式，GLP动物和尸体测试（AIM 2）。这笔赠款 将使我们能够完成提交FDA清除所需的所有测试，并开始营销我们的小说， 有影响力的腕部到脑血栓切除术系统，以改善LVO AIS患者的护理。