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
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.
基金:
Nonprofit Central Research Institute Fund of
Chinese Academy of Medical,
Grant/Award Number:2023-JKCS-09; Beijing
Hospitals Authority Clinical Medicine
Development of special funding,
Grant/AwardNumber:YGLX202325;Research
Funding on Translational Medicine from Beijing
Municipal Science and Technology
Commission,Grant/Award Number:
Z221100007422023; BeijingAssociationfor
Science and Technology Youth Talent Support
Program, Grant/Award Number:
BYESS2022081;National Natural Science
Foundation of China, Grant/AwardNumbers:
61975017,82027802,82101389,82102220,
82171278; Science and Technology Innovation
Service Capacity Building Project of Beijing
Municipal Education Commission,
Grant/AwardNumber:
11000023T000002157177
语种:
外文
WOS:
第一作者:
第一作者机构:[1]Capital Med Univ, Xuanwu Hosp, Dept Neurosurg, 45 Changchun St, Beijing 100053, Peoples R China
共同第一作者:
通讯作者:
推荐引用方式(GB/T 7714):
Yusuying Shadamu,Wu Yan,Li Ming,et al.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[J].NEUROPROTECTION.2024,2(4):318-328.doi:10.1002/nep3.63.
APA:
Yusuying, Shadamu,Wu, Yan,Li, Ming,Duan, Jiangang,Chen, Jian...&Ji, Xunming.(2024).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.NEUROPROTECTION,2,(4)
MLA:
Yusuying, Shadamu,et al."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".NEUROPROTECTION 2..4(2024):318-328