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The purpose of this study is to verify the efficacy and safety of the Liquid Embolic System (Tonbridge Medical Tech. Co., Ltd. (Suzhou)) for the treatment of cerebrovascular malformations.
This is a prospective, multi-center, randomized, parallel positive controlled, non-inferiority trial. This clinical trial is conducted at more than 2 centers in China, and patients who intend to be treated with liquid embolic system for cerebrovascular malformations are enrolled. Eligible patients are randomized into experimental group using Liquid Embolic System (Tonbridge) or control group using Onyx Liquid Embolic System (Medtronic) in a 1:1 ratio. The purpose of this study is to evaluate the effectiveness and safety of the Liquid Embolic System (Tonbridge).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liquid Embolic System (Tonbridge) | Experimental |
| |
| Onyx Liquid Embolic System (Medtronic) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liquid Embolic System (Tonbridge) | Device | Endovascular treatment with Liquid Embolic System (Tonbridge). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Targeted Embolization Satisfaction Rate | Targeted embolization satisfaction is defined as achieving ≥50% occlusion of the targeted embolized area after treatment with liquid embolic system, which is determined by immediate postoperative cerebrovascular DSA. | intra-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| mRS score | mRS scores are assessed at each evaluation time point. | 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure |
| GOS score | GOS scores are assessed at each evaluation time point. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Pan | Contact | 18916099975 | jing.pan@ton-bridge.com | |
| Jin Zheng | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Peng Zhang | Xuanwu Hospital, Beijing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital Southern Medical University | Not yet recruiting | Guangzhou | Guangdong | China |
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| Onyx Liquid Embolic System (Medtronic) | Device | Endovascular treatment with Onyx Liquid Embolic System (Medtronic). |
|
| 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure |
| Operation satisfaction rate | The 5-point Likert scale is used to evaluate operation satisfaction from three aspects: visualization, diffusion, and microcatheter withdrawal. "Operation satisfaction rate" is defined as the proportion of investigational devices or comparators with Likert score≥12 points. | intra-procedure |
| Incidence of major adverse events (MAEs) | MAEs are defined as intracranial hemorrhage and ischemic complications. Intracranial hemorrhage included intraoperative hemorrhage (puncture of blood-supplying arteries by catheters or guidewires, rupture of nidus, and injury to blood vessels during withdrawal of catheters) and delayed symptomatic hemorrhage in the postoperative period; and ischemic complications included intraoperative ischemic complications (displacement of liquid embolic agents, thrombosis, and so on) and postoperative symptomatic ischemic stroke. "Incidence of major adverse events" is the proportion of subjects with adverse events using the investigational device or the comparator. | 1 month±7 days, 3 months±30 days post-procedure |
| Incidence of adverse events (AEs) | "Incidence of adverse events" is the proportion of subjects with adverse events using the investigational device or the comparator. | 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure |
| Incidence of serious adverse events (SAEs) | "Incidence of serious adverse events" is the proportion of subjects with serious adverse events using the investigational device or the comparator. | 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure |
| Incidence of device deficiency | Device deficiency is the unreasonable risk that may endanger human health and life safety in the normal use of medical devices during clinical trials, such as labeling errors, quality problems and malfunctions. | 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure |
| Zhujiang Hospital of Southern Medical University | Not yet recruiting | Guangzhou | Guangdong | China |
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| Henan Provincial People's Hospital | Not yet recruiting | Zhengzhou | Henan | China |
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| The First Affiliated Hospital of Zhengzhou University | Active, not recruiting | Zhengzhou | Henan | China |
| General Hospital of Eastern Theater Command | Not yet recruiting | Nanjing | Jiangsu | China |
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| The First Hospital of Jilin University | Not yet recruiting | Changchun | Jilin | China |
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| General Hospital of Northern Theater Command | Not yet recruiting | Shenyang | Liaoning | China |
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| Qilu Hospital of Shandong University | Not yet recruiting | Jinan | Shandong | China |
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| Xuanwu hospital Capital Medical University | Recruiting | Beijing | China |
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| Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital | Recruiting | Chengdu | China |
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| Guangdong Provincial People's Hospital | Not yet recruiting | Guangzhou | China |
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| Anhui Provincial Hospital | Not yet recruiting | Hefei | China |
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| Jining No.1 People's Hospital | Not yet recruiting | Jining | China |
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| Tongji Hospital Tongji Medical College of HUST | Not yet recruiting | Wuhan | China |
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| ID | Term |
|---|---|
| D002538 | Intracranial Arteriovenous Malformations |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020785 | Central Nervous System Vascular Malformations |
| D009421 | Nervous System Malformations |
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D020765 | Intracranial Arterial Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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