Efficacy and Safety of the Liquid Embolic System (Tonbridge) for Endovascular Treatment of Cerebrovascular Malformations
NCT Number: NCT06479343
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Intracranial Arteriovenous Malformations
Interventions: DEVICE: Liquid Embolic System (Tonbridge)|DEVICE: Onyx Liquid Embolic System (Medtronic)
Sponsor: Zhuhai Tonbridge Medical Tech. Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 170
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2026-10
Locations: Nanfang Hospital Southern Medical University, Guangzhou, Guangdong, China|Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong, China|Henan Provincial People's Hospital, Zhengzhou, Henan, 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

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.

Primary Outcome Measures: Targeted Embolization Satisfaction Rate, 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., intra-procedure
Secondary Outcome Measures: mRS score, mRS scores are assessed at each evaluation time point., 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure|GOS score, GOS scores are assessed at each evaluation time point., 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure|Operation satisfaction rate, 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., intra-procedure|Incidence of major adverse events (MAEs), 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., 1 month±7 days, 3 months±30 days post-procedure|Incidence of adverse events (AEs), "Incidence of adverse events" is the proportion of subjects with adverse events using the investigational device or the comparator., 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure|Incidence of serious adverse events (SAEs), "Incidence of serious adverse events" is the proportion of subjects with serious adverse events using the investigational device or the comparator., 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure|Incidence of device deficiency, 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., 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure