Efficacy and Safety of the Liquid Embolic System (Tonbridge) for Endovascular Treatment of Cerebrovascular Malformations
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
Ton-Bridge Medical Tech. Co., Ltd
170 participants
Jun 27, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria12
- 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.
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Interventions
Endovascular treatment with Liquid Embolic System (Tonbridge).
Endovascular treatment with Onyx Liquid Embolic System (Medtronic).
Locations(14)
View Full Details on ClinicalTrials.gov
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NCT06479343