Using a new liquid embolic system to treat brain blood vessel malformations

Efficacy and Safety of the Liquid Embolic System (Tonbridge) for Endovascular Treatment of Cerebrovascular Malformations: a Prospective, Multi-center, Randomized, Parallel Positive Controlled, Non-inferiority Trial

This study is testing a new liquid treatment for brain blood vessel malformations to see if it works as well and is as safe as a current treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 170 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Ton-Bridge Medical Tech. Co., Ltd (Industry-sponsored)
• Locations: 14 sites (Guangzhou, Guangdong and 13 other locations)
• Trial ID: NCT06479343 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of the Liquid Embolic System developed by Tonbridge Medical Tech. Co., Ltd. for treating intracranial arteriovenous malformations. It is a prospective, multi-center, randomized, parallel positive controlled, non-inferiority trial conducted across multiple centers in China. Eligible patients will be randomly assigned to receive either the Tonbridge system or the control Onyx Liquid Embolic System from Medtronic in a 1:1 ratio. The study will assess the effectiveness and safety of the new system compared to the established treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 who are suitable for endovascular treatment of cerebrovascular malformations.

Not a fit: Patients with recent intracranial hemorrhage, severe comorbidities, or other contraindications to the treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective treatment option for patients with cerebrovascular malformations.

How similar studies have performed: Other studies have shown success with similar liquid embolic systems, indicating potential for this approach.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong and 13 other locations

• Nanfang Hospital Southern Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Active_not_recruiting)
• General Hospital of Eastern Theater Command — Nanjing, Jiangsu, China (Not_yet_recruiting)
• The First Hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• General Hospital of Northern Theater Command — Shenyang, Liaoning, China (Not_yet_recruiting)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (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)

Study contacts

• Principal investigator: Peng Zhang — Xuanwu Hospital, Beijing
• Study coordinator: Jing Pan

Conditions Intracranial Arteriovenous Malformations