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The study is a prospective, multi-center, randomized, open, parallel positive control, non-inferiority trial. Patients are randomized 1:1 to either Coil System(Ton-bridgeMT) or Axium Detachable Coil(Medtronic).
The purpose of this study is to assess the safety and effectiveness of the Coil System(Ton-bridgeMT) in the treatment of intracranial aneurysms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Experimental | Coil system(Ton-bridgeMT) |
|
| group B | Active Comparator | Axium Detachable Coil(Medtronic) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coil system(Ton-bridgeMT) | Device | 1. It consists of a push system with a development mark, and a Detachable platinum-tungsten alloy coil which is connected to the push system. It can be used for embolization of intracranial aneurysms, and other neurovascular abnormalities, such as arteriovenous malformation and arteriovenous fistula. |
| Measure | Description | Time Frame |
|---|---|---|
| success rate of occlusion | Number of aneurysms(Raymond Ⅰ and Ⅱ)/number of overall aneurysms*100% | 180 day |
| Measure | Description | Time Frame |
|---|---|---|
| success rate of occlusion | Number of aneurysms(Raymond Ⅰ and Ⅱ)/number of overall aneurysms*100% | intraoperation |
| Recurrence rate | 2. Number of patients with recurrent aneurysms/ number of overall patients*100% |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianmin Liu | Changhai Hospital of Shangha | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan People's Hospital | Zhongshan | Guangdong | China | |||
| Affiliated Hospital of Guizhou Medical University |
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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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|
| Axium Detachable Coil(Medtronic) | Device | 2. It is made up of a push system with a development mark, a platinum-tungsten alloy embolized coil connected to the push system and a manual release device for releasing the coil from the distal end of the push system. It is mainly used for embolization of intracranial aneurysms, and other neurovascular abnormalities, such as arteriovenous malformation and arteriovenous fistula. |
|
| 180 day |
| Guiyang |
| Guizhou |
| China |
| Jiangsu Province Hospital | Nanjin | Jiangsu | China |
| Nanjing Brain Hospital | Nanjing | Jiangsu | China |
| The first hospital of Jilin University | Changchun | Jilin | China |
| First Affiliated Hospital of China Medical University | Shenyang | Liaoning | China |
| Shengjing Hospital affiliated to China Medical University | Shenyang | Liaoning | China |
| Yantai Yuhuangding Hospital | Yantai | Shandong | China |
| Changhai Hospital of Shanghai | Shanghai | Shanghai Municipality | China |
| Tangdu Hospital of The Fourth Military Medical University | Xi’an | Shanxi | China |
| The Second Affiliated hospital of Zhejiang University School of Medicine | Hanzhou | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | China |
| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |