Clinical trial NCT06479343: Efficacy and Safety of the Liquid Embolic System (Tonbridge) for Endovascular Treatment of Cerebrovascular Malformations
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intracranial Arteriovenous Malformations
Lead sponsor: Ton-Bridge Medical Tech. Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-06-28
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a prospective, multi-center, randomized, parallel positive controlled, non-inferiority trial. This clinical trial is conducted at more than 2 centers in China, and patients who intend to be treated with liquid embolic system for cerebrovascular malformations are enrolled. Eligible patients are randomized into experimental group using Liquid Embolic System (Tonbridge) or control group using Onyx Liquid Embolic System (Medtronic) in a 1:1 ratio. The purpose of this study is to evaluate the effectiveness and safety of the Liquid Embolic System (Tonbridge).

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.

Primary outcomes:
measure: Targeted Embolization Satisfaction Rate
timeFrame: intra-procedure
Secondary outcomes:
measure: mRS score
timeFrame: 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure
measure: GOS score
timeFrame: 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure
measure: Operation satisfaction rate
timeFrame: intra-procedure
measure: Incidence of major adverse events (MAEs)
timeFrame: 1 month±7 days, 3 months±30 days post-procedure
measure: Incidence of adverse events (AEs)
timeFrame: 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure
measure: Incidence of serious adverse events (SAEs)
timeFrame: 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure
measure: Incidence of device deficiency
timeFrame: 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Provincial People&#39;s Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Nanjing
country: China
facility: General Hospital of Eastern Theater Command
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Beijing
country: China
facility: Xuanwu hospital Capital Medical University
city: Chengdu
country: China
facility: Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Hefei
country: China
facility: Anhui Provincial Hospital
city: Jining
country: China
facility: Jining No.1 People's Hospital
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical College of HUST
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Peng Zhang
role: PRINCIPAL_INVESTIGATOR
References: