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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intracranial Arteriovenous Malformations
- Sponsor
- Zhuhai Tonbridge Medical Tech. Co., Ltd.
- Enrollment
- 170
- Locations
- 14
- Primary Endpoint
- Targeted Embolization Satisfaction Rate
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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).
Investigators
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;
Outcomes
Primary Outcomes
Targeted Embolization Satisfaction Rate
Time Frame: 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 Outcomes
- GOS score(1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure)
- Incidence of adverse events (AEs)(1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure)
- Operation satisfaction rate(intra-procedure)
- Incidence of major adverse events (MAEs)(1 month±7 days, 3 months±30 days post-procedure)
- mRS score(1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure)
- Incidence of device deficiency(3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure)
- Incidence of serious adverse events (SAEs)(1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure)