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Clinical Trials in China / NCT06479343
Recruiting Not applicable

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

NCT06479343 · tracked via the Priya Life Science China tracker
Sponsor
Ton-Bridge Medical Tech. Co., Ltd
Phase
Not applicable
Started
2024-06-27
Last updated
2024-09-19

Condition(s) studied

Intracranial Arteriovenous Malformations

Investigational drug(s) / intervention(s)

Liquid Embolic System (Tonbridge)Onyx Liquid Embolic System (Medtronic)

Liquid Embolic System (Tonbridge): Endovascular treatment with Liquid Embolic System (Tonbridge).

Onyx Liquid Embolic System (Medtronic): Endovascular treatment with Onyx Liquid Embolic System (Medtronic).

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
Nanfang Hospital Southern Medical University Guangzhou Guangdong Not Yet Recruiting
Zhujiang Hospital of Southern Medical University Guangzhou Guangdong Not Yet Recruiting
Henan Provincial People's Hospital Zhengzhou Henan Not Yet Recruiting
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan Active Not Recruiting
General Hospital of Eastern Theater Command Nanjing Jiangsu Not Yet Recruiting
The First Hospital of Jilin University Changchun Jilin Not Yet Recruiting
General Hospital of Northern Theater Command Shenyang Liaoning Not Yet Recruiting
Qilu Hospital of Shandong University Jinan Shandong Not Yet Recruiting
Xuanwu hospital Capital Medical University Beijing China Recruiting
Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital Chengdu China Recruiting
Guangdong Provincial People's Hospital Guangzhou China Not Yet Recruiting
Anhui Provincial Hospital Hefei China Not Yet Recruiting
Jining No.1 People's Hospital Jining China Not Yet Recruiting
Tongji Hospital Tongji Medical College of HUST Wuhan China Not Yet Recruiting

More Ton-Bridge Medical Tech. Co., Ltd trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06479343 on ClinicalTrials.gov ↗ ← All trials in China