Efficacy and Safety of the Liquid Embolic System (Tonbridge) for Endovascular Treatment of Cerebrovascular Malformations

NCT ID: NCT06479343

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-27

Study Completion Date

2026-10-31

Brief Summary

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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

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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).

Conditions

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Intracranial Arteriovenous Malformations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Liquid Embolic System (Tonbridge)

Group Type EXPERIMENTAL

Liquid Embolic System (Tonbridge)

Intervention Type DEVICE

Endovascular treatment with Liquid Embolic System (Tonbridge).

Onyx Liquid Embolic System (Medtronic)

Group Type ACTIVE_COMPARATOR

Onyx Liquid Embolic System (Medtronic)

Intervention Type DEVICE

Endovascular treatment with Onyx Liquid Embolic System (Medtronic).

Interventions

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Liquid Embolic System (Tonbridge)

Endovascular treatment with Liquid Embolic System (Tonbridge).

Intervention Type DEVICE

Onyx Liquid Embolic System (Medtronic)

Endovascular treatment with Onyx Liquid Embolic System (Medtronic).

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ton-Bridge Medical Tech. Co., Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peng Zhang

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

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Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status NOT_YET_RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status ACTIVE_NOT_RECRUITING

General Hospital of Eastern Theater Command

Nanjing, Jiangsu, China

Site Status NOT_YET_RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, China

Site Status NOT_YET_RECRUITING

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Site Status NOT_YET_RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status NOT_YET_RECRUITING

Xuanwu hospital Capital Medical University

Beijing, , China

Site Status RECRUITING

Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital

Chengdu, , China

Site Status RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, , China

Site Status NOT_YET_RECRUITING

Anhui Provincial Hospital

Hefei, , China

Site Status NOT_YET_RECRUITING

Jining No.1 People's Hospital

Jining, , China

Site Status NOT_YET_RECRUITING

Tongji Hospital Tongji Medical College of HUST

Wuhan, , China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Jing Pan

Role: CONTACT

18916099975

Jin Zheng

Role: CONTACT

Facility Contacts

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Wenfeng Feng

Role: primary

Chuanzhi Duan

Role: primary

Tianxiao Li

Role: primary

Xin Zhang

Role: primary

Xuan Chen

Role: primary

Guobiao Liang

Role: primary

Donghai Wang

Role: primary

Peng Zhang

Role: primary

Tian Zhang

Role: primary

Guangzhong Chen

Role: primary

Ge Gao

Role: primary

Feng Lei

Role: primary

Jiang Xiaobing

Role: primary

Other Identifiers

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SZTQ202401

Identifier Type: -

Identifier Source: org_study_id

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