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 这项提案的长期目标是改善大血管阻塞患者的护理 急性缺血性中风(LVO AIS)。急诊导管取栓术是一种公认的治疗方法。 用于LVO AIS。尽管如此，仍然存在很大的限制。 对远端、颅内血管的快速插管是成功的基本特征 血栓切除手术。考虑到许多或大多数血栓摘除术患者的高龄， 从股动脉到颈动脉区域时，经常会遇到弯曲的血管。它有 已经证明，在经股动脉取栓术中，大量的曲折会导致更差的结果 程序。 因此，许多领先的干预者建议用经桡动脉入路(TRA)代替经股动脉入路。 进入。在介入心脏病学中，TRA是绝大多数患者的首选途径， 鉴于出血并发症发生率低，且易于进入冠脉循环。放射状场地 还提供了通向脑血管系统的便捷通道，绕过了沿着主动脉弓的曲折， 降主动脉和髂股系统。 许多神经干预学家已经接受了TRA作为诊断程序。然而，即使TRA 将提供比经股动脉途径更容易的途径进行血栓摘除手术 对于曲折的患者，很少有医生使用TRA来治疗这些患者。初级阶段 扩大TRA取栓术的障碍与持续缺乏放射状特异通路和 介入工具，必须针对小径的桡动脉以及 从锁骨下到颈动脉领地航行的特殊几何挑战。 在这个第一阶段的STTR计划中，我们将开发和测试一种新型的大口径血栓切除术系统 适用于TRA。具体地说，我们的手腕到脑血栓切除系统是一个三合一设备， 将导管套、导尿管和远端导尿管组合到一个设备中。这 创新将需要在直接动脉通路、抗扭结和远端柔韧性方面取得具体进展。如果 成功，我们的W2b血栓清除系统将加强对高度曲折的老年患者的护理 患有左心室肥厚的血管病患者。