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)
Targeted Embolization Satisfaction Rate — intra-procedure 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.
Trial sites (14)
Facility
City
Region
Status
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
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.