Intracranial Aneurysms Clinical Trial
Official title:
The Efficacy and Safety Study on Endovascular Embolization of Intracranial Aneurysms With Coil System(Ton-bridgeMT)
Verified date | April 2021 |
Source | Zhuhai Tonbridge Medical Tech. Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 256 |
Est. completion date | September 2, 2020 |
Est. primary completion date | January 3, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Age 18-80 years. - Subject has a target intracranial aneurysm (IA) diagnosed by DSA, and intended to be embolised with coil system. - Subject or guardian is able to understand the purpose of study, agrees to comply with protocol requirements and has provided written informed consent. Exclusion Criteria: - Subject is diagnosed as multiple aneurysms. - Subject is diagnosed as intracranial bulloid, fusiform, false, dissectimng, infective aneurysm or with arteriovenous malformation. - mRS score=3. - Hunt and Hess classification=4. - Subject has emergency ruptured aneurysms and needs assisting stent. - The target aneurysm has received endovascular embolization or surgical treatment. - The aneurysm carrier artery has severe stenosis. - PLT<60×109/L or INR>1.5. - Subject has nonfunction of important organs or other severe diseases. - Major surgery in the last 30 days, or intending to receive surgical treatment in 90 days after enrollment. - Subject is allergic to antiplatelet drugs, anticoagulants, anesthetics, contrast agents or any related contraindication. - History of allergies to platinum and tungsten. - Expected life <12 months. - Pregnant or lactating women. - Subject has participated in any other drug or medical device clinical trials in 1 month before writting informed consent . - Other circumstances judged by researchers are not suitable for enrollment . |
Country | Name | City | State |
---|---|---|---|
China | The first hospital of Jilin University | Changchun | Jilin |
China | Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou |
China | The Second Affiliated hospital of Zhejiang University School of Medicine | Hanzhou | |
China | Jiangsu Province Hospital | Nanjin | Jiangsu |
China | Nanjing Brain Hospital | Nanjing | Jiangsu |
China | Changhai Hospital of Shanghai | Shanghai | Shanghai |
China | First Affiliated Hospital of China Medical University | Shenyang | Liaoning |
China | Shengjing Hospital affiliated to China Medical University | Shenyang | Liaoning |
China | Tangdu Hospital of The Fourth Military Medical University | Xi'an | Shanxi |
China | Yantai Yuhuangding Hospital | Yantai | Shandong |
China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | |
China | Zhongshan People's Hospital | Zhongshan | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Zhuhai Tonbridge Medical Tech. Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | success rate of occlusion | Number of aneurysms(Raymond ? and ?)/number of overall aneurysms*100% | 180 day | |
Secondary | success rate of occlusion | Number of aneurysms(Raymond ? and ?)/number of overall aneurysms*100% | intraoperation | |
Secondary | Recurrence rate | 2. Number of patients with recurrent aneurysms/ number of overall patients*100% | 180 day |
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