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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
170
Endovascular treatment with Liquid Embolic System (Tonbridge).
Endovascular treatment with Onyx Liquid Embolic System (Medtronic).
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGZhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
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.
Time frame: intra-procedure
mRS score
mRS scores are assessed at each evaluation time point.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 month±7 days, 3 months±30 days post-procedure
Jin Zheng
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Henan Provincial People's Hospital
Zhengzhou, Henan, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
ACTIVE_NOT_RECRUITINGGeneral Hospital of Eastern Theater Command
Nanjing, Jiangsu, China
NOT_YET_RECRUITINGThe First Hospital of Jilin University
Changchun, Jilin, China
NOT_YET_RECRUITINGGeneral Hospital of Northern Theater Command
Shenyang, Liaoning, China
NOT_YET_RECRUITINGQilu Hospital of Shandong University
Jinan, Shandong, China
NOT_YET_RECRUITINGXuanwu hospital Capital Medical University
Beijing, China
RECRUITINGSichuan Academy of Medical Sciences Sichuan Provincial People's Hospital
Chengdu, China
RECRUITING...and 4 more locations
Incidence of adverse events (AEs)
"Incidence of adverse events" is the proportion of subjects with adverse events using the investigational device or the comparator.
Time frame: 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.
Time frame: 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.
Time frame: 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure