Efficacy and Safety of the Liquid Embolic System (Tonbridge) for Endovascular Treatment of Cerebrovascular Malformations

Recruiting now · Not applicable

Conditions studied: Intracranial Arteriovenous Malformations

In brief

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.

Key facts

Study ID

NCT06479343

Run by

Ton-Bridge Medical Tech. Co., Ltd

People needed

170

Starts

2024-06-27

Expected to finish

2026-10-01

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 to 80 years, any gender;
• 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.

You may not qualify if…

• Intracranial hemorrhage within 1 month prior to treatment;
• 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.

Where it is running

• Xuanwu hospital Capital Medical University — Beijing, China (enrolling)
• Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital — Chengdu, China (enrolling)
• 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
• Guangdong Provincial People's Hospital — Guangzhou, China
• Anhui Provincial Hospital — Hefei, China
• Jining No.1 People's Hospital — Jining, China
• Nanfang Hospital Southern Medical University — Guangzhou, Guangdong, China
• Tongji Hospital Tongji Medical College of HUST — Wuhan, China
• Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China

Full record on ClinicalTrials.gov

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