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到单个设备中。

• 批准号: 10254745
• 负责人: DAVID F KALLMES
• 金额: $ 49.01万
• 依托单位: CONWAY MEDICAL LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-15 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10254745
• 关键词: Acute; Address; Adoption; Anatomy; Animal Testing; Area; Arteries; Blood Vessels; Blood coagulation; Brain; Bypass; Cadaver; Caliber; Cardiology; Caring; Catheterization; Catheters; Cause of Death; Cerebrovascular system; Cerebrum; Clinical; Coagulation Process; Coronary; Coronary Circulation; Custom; Descending aorta; Development; Device Designs; Devices; Diagnostic Procedure; Dilator; Distal; Elderly; Engineering; Environment; Freezing; Friction; Goals; Health Services Accessibility; Hemorrhage; In Vitro; Inguinal region; Intervention; Ischemic Stroke; Leg; Libraries; Mechanics; Neurological outcome; Outcome; Patient Care; Patient-Focused Outcomes; Patients; Phase; Physicians; Physiological; Polymers; Procedures; Process; Radial; Resistance; Risk; Role; Route; Site; Small Business Technology Transfer Research; Spasm; Speed; Stroke; Suction; Surface; System; Testing; Thinness; Thrombectomy; Withdrawal; Wrist; aortic arch; base; design; disability; experience; femoral artery; improved; in vivo; in vivo evaluation; innovation; member; multidisciplinary; novel; older patient; porcine model; post stroke; pre-clinical; programs; radial artery; replicator; standard of care; tool

PROJECT SUMMARY/ABSTRACT This proposal’s long-term goal is to improve the care of patients suffering from Large Vessel Occlusion Acute Ischemic stroke (LVO AIS). Emergent, catheter-based thrombectomy is an established treatment for LVO AIS. Still, substantial limitations remain. Rapid catheterization of distal, intracranial vessels represents an essential feature of successful thrombectomy procedures. 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 transfemoral thrombectomy procedures. Thus, many leading interventionalists have proposed transradial access (TRA) in place of transfemoral access. Within interventional cardiology, TRA is the preferred access site for the vast majority of patients, 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. Many neurointerventionalists have embraced TRA for diagnostic procedures. However, even though TRA would provide substantially easier access than transfemoral access for thrombectomy procedures in patients with substantial tortuosity, few practitioners use TRA for treatment for these patients. The primary impediment to expansion of TRA thrombectomy relates to an ongoing dearth of radial-specific access and interventional tools, which must be customized to the small diameter of the radial artery as well as the specific geometric challenges in navigating from the subclavian to carotid territories. In this Phase 1 STTR program, we will develop and test a novel large-bore thrombectomy system appropriate for TRA. Specifically, our Wrist-to-Brain thrombectomy system is a 3-in-1 device that combines access sheath, guiding catheter, and distal access catheter in to a single device. This innovation will require specific advances in direct arterial access, kink resistance, and distal suppleness. If successful, our W2B thrombectomy system will enhance care of elderly patients with highly tortuous vasculature who present with LVO AIS.

项目摘要/摘要 该提议的长期目标是改善患有大血管闭塞的患者的护理 急性缺血性中风（LVO AIS）。新兴，基于导管的血栓切除术是已建立的治疗 对于LVO AIS。尽管如此，仍然存在重大限制。 远端，颅内视频的快速导管代表成功的基本特征 血栓切除术。考虑到许多或大多数大多数血栓切除术的高龄，高度 从股骨到颈动脉领土穿越时，经常会遇到曲折的视频。它有 结果表明，大量的曲折性导致thrsprsporal血栓切除术的预后较差 程序。 这是许多领先的介入主义者提出的跨性别通道（TRA）代替了经济 使用权。在介入心脏病学中，TRA是绝大多数患者的首选访问站点， 鉴于出血并发症发生率较低，并且可以随时进入冠状动脉循环。径向部位 还可以随时可以进入大脑脉管系统，绕过主动脉弓的曲折， 降主动脉和ILIO-FEAMORAL系统。 许多神经干预主义者都接受了TRA进行诊断程序。但是，即使 与跨股权访问血栓切除术相比，可以提供更容易的访问 曲折的严重曲折患者，很少有从业者使用TRA治疗这些患者。主要 扩展TRA血栓切除术的障碍与径向特异性通道的持续死亡有关 介入的工具，必须定制为径向动脉的小直径以及 从锁骨下到颈动脉领土，在导航时面临特定的几何挑战。 在此阶段1 STTR计划中，我们将开发和测试一种新型的大孔血栓切除术系统 适合Tra。具体而言，我们 将访问鞘，引导导管和远端访问导管进入单个设备。这 创新将需要在直接动脉通道，扭结阻力和远端柔性方面的特定进步。如果 成功，我们的W2B血栓切除术系统将增强对老年患者的护理 与LVO AIS一起出席的脉管系统。