Single-arm Study of Flow Diverter(Ton-bridgeMT) For Treating Intracranial Aneurysms
Study Details
Study Description
Brief Summary
The purpose of this study is assess the effectiveness and safety of the flow diverter(Ton-bridgeMT) by collecting data obtained by subjects who receive endovascular treatment of intracranial aneurysms.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
This is a prospective, multi-center, single-arm designed trail carried out in 7 research centers over China. The products used by 141 subjects are The Flow Diverter designed by Ton-bridgeMT, an intracranial implant designed to be placed in a parent artery so as to divert blood flow away from an aneurysm.
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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Outcome Measures
Primary Outcome Measures
- Complete occlusion rate of aneurysms [360±30 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.
- Successful occlusion rate of aneurysms [360±30 days]
m 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. Successful occlusion is defined as Raymond class I or class II.
Other Outcome Measures
- The rate of stoke in the target artery and neurologic death [360±30 days]
Stoke in the target artery is defined as new-onset stoke and National Institute of Health stroke scale(NIHSS) increased by at least 4 compared with the baseline.
- The rate of procedure-related complication [Intraoperation]
Procedure-related complications include but not limit to not fully-extended stent, Stent shift, Stent into the aneurysm, Stent thrombosis.
- The rate of stroke [30±7 days / 360±30 days]
The rate of Hemorrhagic stroke as well as symptomatic ischemic stroke.
- The rate of the target vessel stenosis more that 50% [360± 30 days]
The subjects receive DSA(Digital subtraction angiography) examination in 360 days at the 12 months follow-up.
- The rate of the target vessel occlusion [360± 30 days]
The subjects receive DSA examination in 360 days at the 12 months follow-up.
- The rate of AE [Preoperation / Intraoperation / 14 hours / 30± 7 days / 90± 14 days / 180± 30 days / 360± 30 days]
The definition of AE(Adverse Event) refers to ISO 14155
- The rate of SAE [Preoperation / Intraoperation / 14 hours / 30± 7 days / 90± 14 days / 180± 30 days / 360± 30 days]
The definition of SAE (Serious Adverse Event) refers to ISO 14155
- Death rate [30±7 days / 360±30 days]
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 solitary intracranial 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 or the body-neck-rato <2, 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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Aneurysmal associated 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 ≥3
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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, severe narrowing or occlusion of the feeding artery);
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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, stent in the target artery. 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 lactating within the study period.
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Subject has participated in any other drug or medical device clinical investigations 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 Wannan Medical College | Wuhu | Anhui | China | |
| 2 | Zhujiang Hospital of Southern Medical University | Guangzhou | Guangdong | China | |
| 3 | Henan provincial People's Hostpital | Zhengzhou | Henan | China | |
| 4 | Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu | China | |
| 5 | General Hospital of Northern Theater Command | Shenyang | Liaoning | China | |
| 6 | Changhai Hospital of Shanghai | Shanghai | Shanghai | China | |
| 7 | Huashan Hospital Affiliated to Fudan University | Shanghai | Shanghai | 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.- ZHTQ2021002