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 这项建议将改善急性缺血性中风(AIS)患者的护理。以导管为基础 血栓切除术已被确定为AIS的标准治疗方法。尽管如此，仍然存在很大的限制：50% 的患者实现了首次血栓清除，这是良好神经预后的最佳预测指标，这主要是由于 该方法(经股动脉入路[TFA])和目前用于抽吸血栓的导管存在缺陷。 考虑到许多或大多数血栓摘除者的高龄，高度扭曲的血管经常 在从股动脉到颈动脉区域穿越时遇到。已有证据表明， 曲折会导致TFA过程中更糟糕的结果。因此，许多主要的干预主义者提出了 经桡动脉入路(TRA)取代股动脉入路。Tra已经成为广大用户的首选访问站点 大多数介入性心脏病手术，出血并发症发生率低，且易于获得 冠状循环。放射状部位也提供了通向脑血管的便捷通道，绕过 沿着主动脉弓、降主动脉和髂股系统弯曲。然而，神经干预主义者 使用TRA的人使用股骨引导套(如道碴或Neuron Max)时会卡住，而不是 专为从放射状到颅内的导航而设计，由于血管痉挛或 桡动脉闭塞可能是由于他们对TRA的适应不完善所致。 在神经干预方面的一个平行进展是超大口径远端通路导管(DAC)用于 有效地从AIS患者的动脉中取出血栓。这些超大口径DAC提供了 流明(与传统的DAC相比，吸力增加了30%)，但在 曲折的解剖结构，近一半的手术导致无法导航到血块表面。当他们 在DAC规模方面提供重大进步，SuperBores尚未考虑用于TRA方法，原因是 它们厚厚的墙壁和僵硬的尖端，使其无法实现最佳导航或从 径向进场。我们的团队在美敦力收购了我们的 之前由SBIR资助的计划通过对50多名医生的密集采访进行。 在我们成功的第一阶段项目中，我们开发并测试了我们的新型超大口径血栓切除术系统 适用于TRA。具体地说，我们的“手腕到大脑”血栓切除系统提供了明显的优势 特点：(1)将导尿管和超大口径DAC结合在一根导管中；(2)超薄壁由我们的 新的，专有的衬垫，和(3)高度可跟踪和抗扭结的轴，仍然适合在 大多数病人。在这个第二阶段的SBIR计划中，我们提出了一个由FDA指导的全面、正式的验证计划 测试标准(目标1)，然后是广泛的台式、GLP动物和身体测试(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，并开始营销我们的小说和 有效的腕部脑血栓摘除系统，以改善左心室闭塞症患者的护理。