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A trial to evaluate the safety and efficacy of the Tubridge Plus flow-diverter stent for the treatment of intracranial wide-necked aneurysms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microport NeuroTech Tubridge Plus flow-diverter Stent | Device | Intracranial stent for wide-necked aneurysms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete occlusion(Raymond I) rate of aneurysm at 6 months after procedures | Complete occlusion(Raymond I) rate of aneurysm at 6 months after procedures | 6months±30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Complete occlusion(Raymond I) rate of aneurysm at 12 months after procedures | Complete occlusion(Raymond I) rate of aneurysm at 12 months after procedures | 12months±60 days |
| Successful treatment(Raymond I or II)rate of aneurysm at 6 months after procedures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huina Lu | Contact | 15901703529 | HuiNa.Lu@microport.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianmin Liu | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Not yet recruiting | Chendu | China |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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uccessful treatment(Raymond I or II)rate of aneurysm at 6 months after procedures |
| 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 | 12months±60 days |
| Retreatment rate of target aneurysm during follow-up | Retreatment rate of target aneurysm during follow-up | 12months±60 days |
| Success rate of stent implantation | Success rate of stent implantation | 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; | 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 | 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 | 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 | 12months±60 days |
| Huashan Hospital of Fudan University | Recruiting | Shanghai | China |
|
| Shanghai Changhai Hospital | Not yet recruiting | Shanghai | China |
|
| Clinical Research Ethics Committee of Shenzhen Second People's Hospital | Not yet recruiting | Shenzhen | China |
|
| Zhongnan Hospital, Wuhan University | Not yet recruiting | Wuhan | China |
|
| The Second Affiliated Hospital of PLA Air Force Military Medical University | Recruiting | Xi'an | China |
|
| First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | China |
|
| Zhujiang Hospital,Southern Medical University | Recruiting | Zhujiang | China |
|
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |