Flow Diverter(Ton-bridgeMT) For Treating Intracranial Aneurysms
Study Details
Study Description
Brief Summary
This is a prospective, multi-center, randomized, open, parallel positive control, non-inferiority trail. The purpose of this study is assess the effectiveness and safety of the flow diverter(Ton-bridgeMT) by comparing with the data obtained by Tubridge for the endovascular treatment of intracranial aneurysms.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
The Flow Diverter is an intracranial implant designed to be placed in a parent artery so as to divert blood flow away from an aneurysm. This clinical trial is carried out in 14 research centers. The subjects are randomly divided into the experimental group using flow diverter(Ton-bridgeMT) and the control group using Tubridge at a ratio of 1:1.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group A Flow diverter(Ton-bridgeMT, China) |
Device: Flow diverter(Ton-bridgeMT, China)
The device is a self-expanding vascular stent system, which consists of a stent and a delivery system. The stent is made of platinum core nickel-titanium alloy material. The delivery system is composed of a delivery guide wire and an introduction sheath. The stent and the delivery guide wire are pre-installed in the introduction sheath.
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| Active Comparator: Group B Tubridge(Microport, China) |
Device: Tubridge(Microport, China)
Tubridge consists of a stent system and a microcatheter system. The stent system consists of a stent and a conveyor, the stent is self-expanding as well.
|
Outcome Measures
Primary Outcome Measures
- Complete occlusion rate of aneurysms [360±45 days]
The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the rate of aneurysm occlusion at the time of primary endpoint assessment (12 months). Occlusion rates were reported as Class I: complete obliteration; Class II: residual neck; Class III: residual aneurysm.
Secondary Outcome Measures
- Success rate of operation [Intraoperation]
Successful operation represents that the positioning of the test stent is accurate and effectively covers the aneurysm neck after intraoperative DSA(Digital subtraction angiography) examination of the vessels.
- Complete occlusion rate of aneurysms [180±30days]
The Raymond-Roy intracranial aneurysm occlusion classification was used to assess the occlusion rate of aneurysms, class I means complete occlusion of the aneurysms.
- Subtotal occlusion rate [360±45 days]
Subtotal occlusion is defined as less than 10% of the contrast agent in the aneurysm.
Other Outcome Measures
- The rate of stroke [Up to 1 year]
Stroke includes symptomatic ischemic stroke and hemorrhagic stroke.
- The rate of the target vessel stenosis more that 50% and 100% [360±45 days]
The subjects receive DSA examination in 360 days at the 12 months follow-up.
- Procedure-related complication [Intraoperation]
Procedure-related complications include but are not limited to: incomplete stent opening, stent displacement, stent entry into the tumor, stent thrombosis, operation injury.
- The rate of AE/SAE [Up to 1 year]
The definition of AE(Adverse Event) / SAE (Serious Adverse Event) refers to ISO 14155
- Death rate [Up to 1 year]
Subjects who died from any cause would be counted.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18 to 80 years.
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Subject has unruptured aneurysms located in Vertebral artery(VA) or Internal Carotid Artery(ICA) diagnosed by DSA；
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The neck width of the aneurysm ≥4 mm, the max diameter of the aneurysm body ≥10 mm.
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The diameter of the target vessel is 2.0 to 6.5mm.
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Subject or legal representative is able to understand the purpose of study, agrees to comply with protocol requirements and has provided written informed consent.
Exclusion Criteria:
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Diagnosed as multiple aneurysms that can't be treated by single device or with arteriovenous malformation.
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Subject had a subarachnoid hemorrhage within 30 days prior to the enrollment date.
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Modified Rankin Scale(mRS) score >2
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Platelet(PLT)<60*10^9/L or International Normalized Ratio(INR)>1.5
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Heart, lung, liver, kidney failure or other serious diseases (such as brain tumors, systemic infection, active disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe mental illness);
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Lesions judged by researchers that are not suitable for stent delivery and deployment (such as severe stenosis of the tumor-bearing artery, too tortuous tumor-bearing artery, and the stent cannot reach the lesion, etc.)
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Have undergone major surgery within 30 days before enrollment or plan to undergo surgery within 180 days after enrollment.
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History of allergies to antiplatelet drugs, anticoagulants, anesthetics, contrast agents.
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History of allergies to platinum and tungsten.
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Expected life <12 months.
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Female subjects who are pregnant or planning to become pregnant or lactate within the study period.
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Subject has participated in any other drug or medical device clinical trials in 1 month before signing informed consent .
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Other circumstances judged by researchers that are not suitable for enrollment .
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The First Affiliated Hospital of USTC | Hefei | Anhui | China | |
| 2 | Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | China | |
| 3 | Zhujiang Hospital of Southern Medical University | Guangzhou | Guangdong | China | |
| 4 | Zhuhai people's hospital | Zhuhai | Guangdong | China | |
| 5 | The people's hospital of Guangxi Zhuang Autonomous Region | Nanning | Guangxi | China | |
| 6 | Henan provincial People's Hostpital | Zhengzhou | Henan | China | |
| 7 | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | China | |
| 8 | Zhongnan Hospital of Wuhan University | Wuhan | Hubei | China | |
| 9 | Xiangya Hospital Central South University | Changsha | Hunan | China | |
| 10 | Jiangsu Province hospital | Nanjing | Jiangsu | China | |
| 11 | The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China | |
| 12 | Changhai Hospital of Shanghai | Shanghai | Shanghai | China | |
| 13 | Huashan Hospital Affiliated to Fudan University | Shanghai | Shanghai | China | |
| 14 | Zhejiang hospital | Hangzhou | Zhejiang | China |
Sponsors and Collaborators
- Zhuhai Tonbridge Medical Tech. Co., Ltd.
Investigators
- Principal Investigator: Jianmin Liu, Changhai Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ZHTQ2020001