A multicenter single-arm objective performance criteria trial evaluating the efficacy and safety of a dedicated venous sinus thrombectomy device for severe cerebral venous sinus thrombosis  

作　　者：Shadamu Yusuying Yan Wu Ming Li Jiangang Duan Jian Chen Yujiao Chen Chen Zhou Hetao Bian Chuanhui Li Chuanjie Wu Ran Meng Xunming Ji 

机构地区：[1]Department of Neurosurgery,Xuanwu Hospital,Capital Medical University,Beijing,China [2]Department of China-America Institute of Neuroscience,Xuanwu Hospital,Capital Medical University,Beijing,China [3]Emergency Department,Xuanwu Hospital,Capital Medical University,Beijing,China [4]Department of Blood Transfusion,Beijing Jishuitan Hospital,Beijing,China [5]Laboratory of Brain Disorders,Ministry of Science and Technology,Collaborative Innovation Center for Brain Disorders,Beijing Institute of Brain Disorders,Beijing Advanced Innovation Center for Big Data-based Precision Medicine,Capital Medical University,Beijing,China [6]Department of Neurology,Stroke Center,Xuanwu Hospital,Capital Medical University,Beijing,China [7]Department of Neurology,Xuanwu Hospital,Capital Medical University,Beijing,China

出　　处：《Neuroprotection》2024年第4期318-328,共11页神经保护(英文)

基　　金：supported by the National Natural Science Foundation of China(82027802,82102220,61975017,82101389,82171278);the Research Funding on Translational Medicine from Beijing Municipal Science and Technology Commission(Z221100007422023);the Beijing Hospitals Authority Clinical Medicine Development of special funding support(YGLX202325);the Nonprofit Central Research Institute Fund of Chinese Academy of Medical(2023-JKCS-09);the Beijing Association for Science and Technology Youth Talent Support Program(BYESS2022081);the Science and Technology Innovation Service Capacity Building Project of Beijing Municipal Education Commission(11000023T000002157177).

摘　　要：Aim:Approximately 21%of patients with cerebral venous sinus thrombosis(CVST)are refractory to anticoagulation treatment and face poor prognosis.These patients may benefit from endovascular therapy.Although numerous studies have reported promising results with endovascular therapy,it remains challenging to obtain convincing evidence of its efficacy and safety due to the unique challenges posed by CVST,such as larger vessel diameters,distinct pathophysiology,and substantial clot burden.Therefore,dedicated endovascular therapy tools should be developed specifically for CVST.This study aimed to evaluate the efficacy and safety of a dedicated venous sinus thrombectomy device in patients with acute or subacute CVST.Methods:This prospective,multicenter,single-arm trial utilized an objective performance criterion design.Enrolled patients received treatment with a dedicated venous sinus thrombectomy device to recanalize occluded sinuses or veins.The primary objective was to compare the immediate postoperative recanalization rate with a preset target value to determine whether the device met the clinical application needs.The trial plans to enroll 146 patients from 11 tertiary medical centers in China.Discussion:This trial is expected to fill a critical gap in endovascular treatments for CVST and support the development of reliable,dedicated thrombectomy devices for future studies.

关 键 词：ANTICOAGULATION cerebral venous sinus thrombosis endovascular treatment thrombectomy devices TRIAL 

分 类 号：R74[医药卫生—神经病学与精神病学]