Coil System(Ton-bridgeMT) for Endovascular Embolization of Cranial Aneurysms
- Conditions
- Intracranial Aneurysms
- Registration Number
- NCT03550638
- Lead Sponsor
- Zhuhai Tonbridge Medical Tech. Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 256
- 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.
- 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 .
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method success rate of occlusion 180 day Number of aneurysms(Raymond Ⅰ and Ⅱ)/number of overall aneurysms\*100%
- Secondary Outcome Measures
Name Time Method success rate of occlusion intraoperation Number of aneurysms(Raymond Ⅰ and Ⅱ)/number of overall aneurysms\*100%
Recurrence rate 180 day 2. Number of patients with recurrent aneurysms/ number of overall patients\*100%
Trial Locations
- Locations (12)
Zhongshan People's Hospital
🇨🇳Zhongshan, Guangdong, China
Affiliated Hospital of Guizhou Medical University
🇨🇳Guiyang, Guizhou, China
Nanjing Brain Hospital
🇨🇳Nanjing, Jiangsu, China
Jiangsu Province Hospital
🇨🇳Nanjin, 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, China
Tangdu Hospital of The Fourth Military Medical University
🇨🇳Xi'an, Shanxi, China
Scroll for more (2 remaining)Zhongshan People's Hospital🇨🇳Zhongshan, Guangdong, China