Efficacy and Safety of the Liquid Embolic System (Tonbridge) for Endovascular Treatment of Cerebrovascular Malformations
- Conditions
- Intracranial Arteriovenous Malformations
- Interventions
- Device: Onyx Liquid Embolic System (Medtronic)Device: Liquid Embolic System (Tonbridge)
- Registration Number
- NCT06479343
- Lead Sponsor
- Zhuhai Tonbridge Medical Tech. Co., Ltd.
- 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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 170
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Onyx Liquid Embolic System (Medtronic) Onyx Liquid Embolic System (Medtronic) - Liquid Embolic System (Tonbridge) Liquid Embolic System (Tonbridge) -
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method GOS score 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure GOS scores are assessed at each evaluation time point.
Incidence of adverse events (AEs) 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure "Incidence of adverse events" is the proportion of subjects with adverse events using the investigational device or the comparator.
Operation satisfaction rate intra-procedure The 5-point Likert scale is used to evaluate operation satisfaction from three aspects: visualization, diffusion, and microcatheter withdrawal. "Operation satisfaction rate" is defined as the proportion of investigational devices or comparators with Likert score≥12 points.
Incidence of major adverse events (MAEs) 1 month±7 days, 3 months±30 days post-procedure MAEs are defined as intracranial hemorrhage and ischemic complications. Intracranial hemorrhage included intraoperative hemorrhage (puncture of blood-supplying arteries by catheters or guidewires, rupture of nidus, and injury to blood vessels during withdrawal of catheters) and delayed symptomatic hemorrhage in the postoperative period; and ischemic complications included intraoperative ischemic complications (displacement of liquid embolic agents, thrombosis, and so on) and postoperative symptomatic ischemic stroke. "Incidence of major adverse events" is the proportion of subjects with adverse events using the investigational device or the comparator.
mRS score 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure mRS scores are assessed at each evaluation time point.
Incidence of device deficiency 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure Device deficiency is the unreasonable risk that may endanger human health and life safety in the normal use of medical devices during clinical trials, such as labeling errors, quality problems and malfunctions.
Incidence of serious adverse events (SAEs) 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure "Incidence of serious adverse events" is the proportion of subjects with serious adverse events using the investigational device or the comparator.
Trial Locations
- Locations (14)
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Nanfang Hospital Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, 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
Xuanwu hospital Capital Medical University
🇨🇳Beijing, China
Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital
🇨🇳Chengdu, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, China
Anhui Provincial Hospital
🇨🇳Hefei, China
Jining No.1 People's Hospital
🇨🇳Jining, China
Tongji Hospital Tongji Medical College of HUST
🇨🇳Wuhan, China