RecruitingNot ApplicableNCT06479343

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


Sponsor

Ton-Bridge Medical Tech. Co., Ltd

Enrollment

170 participants

Start Date

Jun 27, 2024

Study Type

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

Min Age: 18 YearsMax Age: 80 Years

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

DEVICELiquid Embolic System (Tonbridge)

Endovascular treatment with Liquid Embolic System (Tonbridge).

DEVICEOnyx Liquid Embolic System (Medtronic)

Endovascular treatment with Onyx Liquid Embolic System (Medtronic).


Locations(14)

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

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NCT06479343


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