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Recruiting NCT06479343

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

No phase Interventional Intracranial Arteriovenous Malformations

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Liquid Embolic System (Tonbridge), Onyx Liquid Embolic System (Medtronic).
Who it may be relevant to
Registry conditions: Intracranial Arteriovenous Malformations. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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).

Interventions

  • Device Liquid Embolic System (Tonbridge)
    Endovascular treatment with Liquid Embolic System (Tonbridge).
  • Device Onyx Liquid Embolic System (Medtronic)
    Endovascular treatment with Onyx Liquid Embolic System (Medtronic).

Primary outcome measures

  • Targeted Embolization Satisfaction Rate [Time frame: intra-procedure]
Secondary outcome measures (7)
  • mRS score [Time frame: 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure]
  • GOS score [Time frame: 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure]
  • Operation satisfaction rate [Time frame: intra-procedure]
  • Incidence of major adverse events (MAEs) [Time frame: 1 month±7 days, 3 months±30 days post-procedure]
  • Incidence of adverse events (AEs) [Time frame: 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure]
  • Incidence of serious adverse events (SAEs) [Time frame: 1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure]
  • Incidence of device deficiency [Time frame: 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure]

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;
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 14 centers
  • Nanfang Hospital Southern Medical University — Guangzhou
  • Zhujiang Hospital of Southern Medical University — Guangzhou
  • Henan Provincial People's Hospital — Zhengzhou
  • The First Affiliated Hospital of Zhengzhou University — Zhengzhou
  • General Hospital of Eastern Theater Command — Nanjing
  • The First Hospital of Jilin University — Changchun
  • General Hospital of Northern Theater Command — Shenyang
  • Qilu Hospital of Shandong University — Jinan
  • … and 6 more centers

Identifiers

NCT: NCT06479343 · SZTQ202401

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗