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

Last updated: September 3, 2024
Sponsor: Zhuhai Tonbridge Medical Tech. Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Birth Defects

Abnormal Blood Vessels (Arteriovenous Malformations)

Holoprosencephaly

Treatment

Liquid Embolic System (Tonbridge)

Onyx Liquid Embolic System (Medtronic)

Clinical Study ID

NCT06479343
SZTQ202401
  • Ages 18-80
  • All Genders

Study 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 Criteria

Inclusion

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 compliancewith the study protocol and provides a signed informed consent form.

Exclusion

Exclusion Criteria:

  • Intracranial hemorrhage within 1 month prior to treatment;

  • The targeted embolization area needs to receive other treatments (surgicalresection, SRS, other embolic materials) at the same time;

  • Combination of other cerebrovascular malformations, such as cavernous vascularmalformation;

  • Severe stenosis or occlusion of cerebral feeding artery requiring surgicalintervention;

  • 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 anticoagulanttherapy;

  • 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 timeof signing informed consent;

  • Other conditions judged by the investigators as unsuitable for enrollment.

Study Design

Total Participants: 170
Treatment Group(s): 2
Primary Treatment: Liquid Embolic System (Tonbridge)
Phase:
Study Start date:
June 27, 2024
Estimated Completion Date:
October 31, 2026

Study 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).

Connect with a study center

  • Nanfang Hospital Southern Medical University

    Guangzhou, Guangdong
    China

    Site Not Available

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong
    China

    Site Not Available

  • Henan Provincial People's Hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • Henan Provincial People's Hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Site Not Available

  • General Hospital of Eastern Theater Command

    Nanjing, Jiangsu
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin
    China

    Site Not Available

  • General Hospital of Northern Theater Command

    Shenyang, Liaoning
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, Shandong
    China

    Site Not Available

  • Xuanwu hospital Capital Medical University

    Beijing,
    China

    Active - Recruiting

  • Sichuan Academy of Medical Sciences Sichuan Provincial People's Hospital

    Chengdu,
    China

    Active - Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou,
    China

    Site Not Available

  • Anhui Provincial Hospital

    Hefei,
    China

    Site Not Available

  • Jining No.1 People's Hospital

    Jining,
    China

    Site Not Available

  • Tongji Hospital Tongji Medical College of HUST

    Wuhan,
    China

    Site Not Available

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