Intracranial Arteriovenous Malformations
Conditions
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).
Interventions
DEVICELiquid Embolic System (Tonbridge)
Endovascular treatment with Liquid Embolic System (Tonbridge).
DEVICEOnyx Liquid Embolic System (Medtronic)
Endovascular treatment with Onyx Liquid Embolic System (Medtronic).
Sponsors
Ton-Bridge Medical Tech. Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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 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. |
Countries
China
Contacts
Primary ContactJing Pan
Backup ContactJin Zheng
Outcome results
None listed