Enabling rapid and effective stroke thrombectomy procedures from a Transradial approach: Combining introducer sheath, guide catheter, and distal access catheter into a single device.
Enabling rapid and effective stroke thrombectomy procedures from a Transradial approach: Combining introducer sheath, guide catheter, and distal access catheter into a single device.
批准号:
10254745
负责人:
DAVID F KALLMES
金额:
$49.01万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2021
资助国家:
美国
项目状态:
已结题
起止时间:
2021-09-15 至 2023-08-31
关键词:
AcuteAddressAdoptionAnatomyAnimal TestingAreaArteriesBlood VesselsBlood coagulationBrainBypassCadaverCaliberCardiologyCaringCatheterizationCathetersCause of DeathCerebrovascular systemCerebrumClinicalCoagulation ProcessCoronaryCoronary CirculationCustomDescending aortaDevelopmentDevice DesignsDevicesDiagnostic ProcedureDilatorDistalElderlyEngineeringEnvironmentFreezingFrictionGoalsHealth Services AccessibilityHemorrhageIn VitroInguinal regionInterventionIschemic StrokeLegLibrariesMechanicsNeurological outcomeOutcomePatient CarePatient-Focused OutcomesPatientsPhasePhysiciansPhysiologicalPolymersProceduresProcessRadialResistanceRiskRoleRouteSiteSmall Business Technology Transfer ResearchSpasmSpeedStrokeSuctionSurfaceSystemTestingThinnessThrombectomyWithdrawalWristaortic archbasedesigndisabilityexperiencefemoral arteryimprovedin vivoin vivo evaluationinnovationmembermultidisciplinarynovelolder patientporcine modelpost strokepre-clinicalprogramsradial arteryreplicatorstandard of caretool
中文摘要
项目总结/摘要
该提案的长期目标是改善大血管闭塞患者的护理
急性缺血性卒中(LVO AIS)。紧急、基于导管的血栓切除术是一种既定的治疗方法
用于LVO AIS。然而,仍然存在很大的局限性。
远端颅内血管的快速导管插入是成功的颅内血管插管的基本特征。
血栓切除术。考虑到许多或大多数血栓切除术候选人的高龄,
当从股动脉到颈动脉区域穿越时,经常遇到曲折的血管。它有
已经证明,严重迂曲导致经股动脉血栓切除术的结局更差
程序.
因此,许多领先的介入医生建议经桡动脉入路(TRA)代替经股动脉入路。
access.在介入心脏病学中,TRA是绝大多数患者的首选穿刺部位,
因为出血并发症的发生率很低,而且容易进入冠状动脉循环。辐射状部位
还提供了通向脑血管系统的通路,绕过了沿着主动脉弓的迂曲部分,
降主动脉和髂股系统。
许多神经介入医生已经接受TRA用于诊断程序。然而,尽管TRA
将为血栓切除术提供比经股动脉入路更容易的入路,
对于严重迂曲的患者,很少有医生使用TRA治疗这些患者。主
TRA血栓切除术扩张的障碍与持续缺乏桡动脉特异性通路有关,
介入工具,这必须是定制的桡动脉的小直径,以及
在从锁骨下动脉到颈动脉区域的导航中的特定几何挑战。
在这个一期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
适合TRA。具体来说,我们的腕-脑血栓切除系统是一种三合一器械,
将入路鞘管、导引导管和远端入路导管组合到单个器械中。这
创新将需要在直接动脉通路、抗扭结性和远端柔顺性方面取得具体进展。如果
成功后,我们的W2 B血栓切除系统将加强高度迂曲的老年患者的护理,
患有LVO AIS的患者。
英文摘要
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.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
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海外基金