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.

项目概要/摘要 该提案的长期目标是改善大血管闭塞患者的护理 急性缺血性中风 (LVO AIS) 是一种既定的治疗方法。 但对于 LVO AIS 来说，仍然存在很大的局限性。 远端颅内血管的快速插管是成功的一个基本特征 鉴于许多高度或大多数血栓切除术候选人的高龄， 当从股骨区域穿越到颈动脉区域时，经常会遇到弯曲的血管。 研究表明，大量的曲折会导致经股动脉血栓切除术的结果更差 程序。 因此，许多领先的介入医生提出经桡动脉入路 (TRA) 来代替经股动脉入路 在介入心脏病学中，TRA 是绝大多数患者的首选进入部位。 出血并发症发生率低，且易于进入冠状动脉循环。 还提供了进入脑脉管系统的便捷通道，绕过主动脉弓的曲折， 降主动脉和髂股系统。 许多神经介入医生已经接受 TRA 进行诊断程序，但是，即使 TRA 也是如此。 与经股动脉入路相比，在血栓切除术中将提供更容易的入路 对于患有严重迂曲的患者，很少有医生使用 TRA 来治疗这些患者。 TRA 血栓切除术扩展的障碍与桡动脉特异性通路的持续死亡有关 介入工具，必须根据桡动脉的小直径以及桡动脉的直径进行定制 从锁骨下区域导航到颈动脉区域的特定几何挑战。 在这个第一阶段 STTR 项目中，我们将开发和测试一种新型的大口径血栓切除系统 具体而言，我们的腕至脑血栓切除系统是一款三合一设备， 将通路鞘、导管和远端通路引导导管组合成一个装置。 创新需要在直接动脉通路、抗扭结和远端柔软性方面取得具体进展。 我们的 W2B 血栓切除系统取得成功，将加强对患有高度曲折的老年患者的护理 出现 LVO AIS 的脉管系统。