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This clinical trial is to verify the safety and effectiveness of the Non-adhesive Liquid Embolic System(NALES) produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. in the process of clinical use to support the application of the National Medical Products Administration ( NMPA) product registration approval.
A prospective, multicenter, randomized controlled trial was used in this study. Onyx Liquid Embolic System and Marathon Flow Directed Micro Catheter, which were registered and marketed in China and had good effect in the industry, were selected as the control devices. Subjects requiring cerebral arteriovenous malformation embolization were selected to participate in the trial based on pathological conditions and inclusion/exclusion criteria, and the use of test products or control products was determined based on central randomized results. Imaging data involving the main evaluation criteria were evaluated uniformly by the blind evaluators of the leading unit, so as to reduce the bias caused by subjective factors of different evaluators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-adhesive Liquid Embolic System(NALES) | Experimental |
| |
| Onyx Liquid Embolic System& Marathon Flow Directed Micro Catheter | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| embolism | Device | Cerebral arteriovenous malformation embolism |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effective embolization rate of malformed masses | Number of effective embolization subjects / Total number of subjects x 100%.Definition of effective embolization : Postoperative DSA angiographic malformation volume decreased ≥50%. Volume of malformed groups = length × width × height /2. | Immediately after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| MRS score | MRS refers to the modified Rankin scale, which is used to measure the neurological recovery of patients after stroke. It has a scale of zero to six. The higher the score, the worse the neurological function. MRS scores were collected at 1, 6 and 12 months after the operation before discharge . | 1,6,12months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of major adverse events related to device or surgical procedures within 1 month after surgery | Major adverse events related to instrumentation or surgical procedures within 1 month after surgery: bleeding during embolization, catheter indwelling, bleeding after embolization, symptomatic cerebral infarction, and edema. | 1 month after surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianmin Liu, Doctor | Contact | 13901780638 | liu118@vip.163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhujiang Hospital of Southern Medical University | Not yet recruiting | Guangzhou | Guangdong | 510280 | China |
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| Technical success rate |
Success is represented by the ability to reach the lesion and embolize the malformed mass of the intended target, followed by successful catheter withdrawal from the body |
| Immediately after surgery |
| Catheter performance evaluation |
| Immediately after surgery |
| Nan Fang Hospital | Not yet recruiting | Guangzhou | Guangdong | 510515 | China |
|
| Guangdong Provincial People's Hospital | Not yet recruiting | Guangzhou | Guangdong | China |
|
| The First Affiliated Hospital of Harbin Medical University | Not yet recruiting | Harbin | Heilongjiang | China |
|
| Henan Provincial People's Hospital | Recruiting | Zhengzhou | Henan | China |
|
| Zhongnan Hospital of Wuhan University | Not yet recruiting | Wuhan | Hubei | 430071 | China |
|
| The First People's Hospital of Changzhou | Not yet recruiting | Changzhou | Jiangsu | China |
|
| Nanjng Drum Tower Hospital | Not yet recruiting | Nanjing | Jiangsu | 210008 | China |
|
| General Hospital of Eastern Theater Command | Not yet recruiting | Nanjing | Jiangsu | China |
|
| The Second Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | China |
|
| Huashan Hospital ,Fudan University | Not yet recruiting | Shanghai | Shanghai Municipality | China |
|
| Shanghai Changhai Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
|
| The Second Affiliated Hospital of Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | 322000 | China |
|
| ID | Term |
|---|---|
| D002538 | Intracranial Arteriovenous Malformations |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020785 | Central Nervous System Vascular Malformations |
| D009421 | Nervous System Malformations |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D020765 | Intracranial Arterial Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D057505 | Embolic Protection Devices |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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