A trial to evaluate the safety and efficacy of the Tubridge Plus flow-diverter stent for the treatment of intracranial wide-necked aneurysms.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
99
Intracranial stent for wide-necked aneurysms
West China Hospital of Sichuan University
Chendu, China
NOT_YET_RECRUITINGHuashan Hospital of Fudan University
Shanghai, China
RECRUITINGShanghai Changhai Hospital
Shanghai, China
Complete occlusion(Raymond I) rate of aneurysm at 6 months after procedures
Complete occlusion(Raymond I) rate of aneurysm at 6 months after procedures
Time frame: 6months±30 days
Complete occlusion(Raymond I) rate of aneurysm at 12 months after procedures
Complete occlusion(Raymond I) rate of aneurysm at 12 months after procedures
Time frame: 12months±60 days
Successful treatment(Raymond I or II)rate of aneurysm at 6 months after procedures
uccessful treatment(Raymond I or II)rate of aneurysm at 6 months after procedures
Time frame: 6months±30 days
Successful treatment(Raymond I or II)rate of aneurysm at 12 months after procedures
Successful treatment(Raymond I or II)rate of aneurysm at 12 months after procedures
Time frame: 12months±60 days
Retreatment rate of target aneurysm during follow-up
Retreatment rate of target aneurysm during follow-up
Time frame: 12months±60 days
Success rate of stent implantation
Success rate of stent implantation
Time frame: Immediate evaluation after intervention
The proportion of subjects with ipsilateral stroke or neurogenic death to their target aneurysm at 1 month postoperatively, 6 months postoperatively, and 1 year postoperatively;
The proportion of subjects with ipsilateral stroke or neurogenic death to their target aneurysm at 1 month postoperatively, 6 months postoperatively, and 1 year postoperatively;
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Clinical Research Ethics Committee of Shenzhen Second People's Hospital
Shenzhen, China
NOT_YET_RECRUITINGZhongnan Hospital, Wuhan University
Wuhan, China
NOT_YET_RECRUITINGThe Second Affiliated Hospital of PLA Air Force Military Medical University
Xi'an, China
RECRUITINGFirst Affiliated Hospital of Zhengzhou University
Zhengzhou, China
NOT_YET_RECRUITINGZhujiang Hospital,Southern Medical University
Zhujiang, China
RECRUITINGTime frame: 12months±60 days
The proportion of subjects with in-stent stenosis (stenosis ≥50% and <100%) within 6 months after procedures
The proportion of subjects with in-stent stenosis (stenosis ≥50% and \<100%) within 6 months after procedures
Time frame: 6months±30 days
Proportion of subjects with complete in-stent occlusion within 6 months after procedures
Proportion of subjects with complete in-stent occlusion within 6 months after procedures
Time frame: 6months±30 days
Device-related adverse events, serious adverse events within 1 month, 6 months, and 1 year after procedures
Device-related adverse events, serious adverse events within 1 month, 6 months, and 1 year after procedures
Time frame: 12months±60 days