Efficacy and Safety of the Liquid Embolic System (Tonbridge) for Endovascular Treatment of Cerebrovascular Malformations
NCT ID: NCT06479343
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
170 participants
INTERVENTIONAL
2024-06-27
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Liquid Embolic System (Tonbridge)
Liquid Embolic System (Tonbridge)
Endovascular treatment with Liquid Embolic System (Tonbridge).
Onyx Liquid Embolic System (Medtronic)
Onyx Liquid Embolic System (Medtronic)
Endovascular treatment with Onyx Liquid Embolic System (Medtronic).
Interventions
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Liquid Embolic System (Tonbridge)
Endovascular treatment with Liquid Embolic System (Tonbridge).
Onyx Liquid Embolic System (Medtronic)
Endovascular treatment with Onyx Liquid Embolic System (Medtronic).
Eligibility Criteria
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Inclusion Criteria
* Subject is suitable for endovascular treatment of cerebrovascular malformations;
* Subject is able to understand the purpose of the study, shows sufficient compliance with the study protocol and provides a signed informed consent form.
Exclusion Criteria
* The targeted embolization area needs to receive other treatments (surgical resection, SRS, other embolic materials) at the same time;
* Combination of other cerebrovascular malformations, such as cavernous vascular malformation;
* Severe stenosis or occlusion of cerebral feeding artery requiring surgical intervention;
* Intracranial tumor requiring surgical intervention;
* mRS score≥3;
* Heart, lung, liver and renal failure or other severe diseases;
* Known bleeding tendency, such as coagulation dysfunction (INR\>1.5);
* Known allergy to DMSO and contrast media, or contraindication to anticoagulant therapy;
* Pregnant or breastfeeding women, or who plan to become pregnant during the study;
* Subject is participating in other drug or medical device clinical trials at the time of signing informed consent;
* Other conditions judged by the investigators as unsuitable for enrollment.
18 Years
80 Years
ALL
No
Sponsors
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Ton-Bridge Medical Tech. Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Peng Zhang
Role: PRINCIPAL_INVESTIGATOR
Xuanwu Hospital, Beijing
Locations
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Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
General Hospital of Eastern Theater Command
Nanjing, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
General Hospital of Northern Theater Command
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Xuanwu hospital Capital Medical University
Beijing, , China
Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital
Chengdu, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
Anhui Provincial Hospital
Hefei, , China
Jining No.1 People's Hospital
Jining, , China
Tongji Hospital Tongji Medical College of HUST
Wuhan, , China
Countries
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Central Contacts
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Jin Zheng
Role: CONTACT
Facility Contacts
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Wenfeng Feng
Role: primary
Chuanzhi Duan
Role: primary
Tianxiao Li
Role: primary
Xin Zhang
Role: primary
Xuan Chen
Role: primary
Guobiao Liang
Role: primary
Donghai Wang
Role: primary
Peng Zhang
Role: primary
Tian Zhang
Role: primary
Guangzhong Chen
Role: primary
Ge Gao
Role: primary
Feng Lei
Role: primary
Jiang Xiaobing
Role: primary
Other Identifiers
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SZTQ202401
Identifier Type: -
Identifier Source: org_study_id
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