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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
256
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.
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.
Zhongshan People's Hospital
Zhongshan, Guangdong, China
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Jiangsu Province Hospital
Nanjin, Jiangsu, China
success rate of occlusion
Number of aneurysms(Raymond Ⅰ and Ⅱ)/number of overall aneurysms\*100%
Time frame: 180 day
success rate of occlusion
Number of aneurysms(Raymond Ⅰ and Ⅱ)/number of overall aneurysms\*100%
Time frame: intraoperation
Recurrence rate
2\. Number of patients with recurrent aneurysms/ number of overall patients\*100%
Time frame: 180 day
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 2 more locations