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The purpose of this study is to evaluate the safety differences between intracranial support catheter and guide catheter for stent-assisted embolization in the treatment of unruptured intracranial aneurysms in the anterior circulation.
This is a prospective, multicenter, randomized, open, controlled, superiority trial carried out in 9 research centers over China. Patients are randomized 1:1 to therapy either intracranial support catheter or guide catheter. Taking the guide catheter as a control, to evaluate whether the safety of intracranial support catheter for stent-assisted embolization in the treatment of unruptured intracranial aneurysms in the anterior circulation is superior than that of the control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | Intracranial Support Catheter |
|
| control group | Active Comparator | Guide Catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracranial Support Catheter | Device | Endovascular procedure using the intracranial support catheter which approved by NMPA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of symptomatic cerebral infarction within 48 hours postoperation | Symptomatic cerebral infarction is defined as NIHSS score increased by≥4 points compared with preoperation, along with imaging confirmed to be caused by infarction. | within 48 hours postoperation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of new-onset DWI positive postoperation | New-onset DWI positive is defined as any new hyperintense lesions. | within 48 hours postoperation |
| Rate of catheter-related complications | Catheter-related complications are defined as vasospasm, vascular dissection, etc. which caused by catheter during operation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Xu | Contact | 13958119687 | jingxu@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jing Xu | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | China |
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| Guide Catheter | Device | Endovascular procedure using the guide catheter which approved by NMPA |
|
| Intraoperation |
| Incidence of symptomatic cerebral infarction at 7 days postoperation or at discharge | Symptomatic cerebral infarction is defined as NIHSS score increased by≥4 points compared with preoperation, along with imaging confirmed to be caused by infarction. | 7 days postoperation or discharged |
| Rate of mRS score 0-2 at 90 days | mRS score 0-2 indicates good prognosis. | 90±14 days postoperation |
| All-cause mortality within 90 days | All-cause mortality is defined as all deaths due to any cause. | up to 90 days |
| Incidence of Adverse Events (AE) | up to 90 days |
| Incidence of Serious Adverse Events (SAE) | up to 90 days |
| Huzhou Central Hospital | Not yet recruiting | Huzhou | Zhejiang | China |
|
| Lishui Municipal Central Hospital | Not yet recruiting | Lishui | Zhejiang | China |
|
| Lishui People's Hospital | Not yet recruiting | Lishui | Zhejiang | China |
|
| Ningbo First Hospital | Not yet recruiting | Ningbo | Zhejiang | China |
|
| Ningbo Medical Center Lihuili Hospital | Not yet recruiting | Ningbo | Zhejiang | China |
|
| Shaoxing People's Hospital | Not yet recruiting | Shaoxing | Zhejiang | China |
|
| Taizhou Hospital of Zhejiang Province | Not yet recruiting | Taizhou | Zhejiang | China |
|
| The Second Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | Wenzhou | Zhejiang | China |
|
| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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