Liquid embolic treatment for brain arteriovenous malformations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multi-center, open-label, randomized non-inferiority trial comparing a novel liquid embolic agent to the Onyx Liquid Embolic System for embolization of brain arteriovenous malformations and arteriovenous fistulas. About 116 adults with a single Spetzler‑Martin grade I–IV AVM deemed suitable for embolization will be randomized to receive one of the two devices. Participants will be seen before the procedure, at discharge, and at 1 month, 6 months, and 12 months after the first embolization, with unscheduled visits as needed to capture safety and effectiveness data. Imaging and clinical outcome measures will be collected to determine whether the new agent achieves non-inferior obliteration rates and acceptable safety compared with Onyx.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 and ≤ 80 years at the time of signing the informed consent
* Subjects with brain arteriovenous malformation diagnosed by CT/MRI/DSA
* The target brain arteriovenous malformation is classified by Spetzler-Martin in the range of Ⅰ \~ Ⅳ
* Subjects themselves and/or their guardian are able to understand the purpose of the study, consent to participate, and sign the informed consent form
* Brain arteriovenous malformations deemed suitable for liquid embolic agent intervention as assessed by the investigator

Exclusion Criteria:

* Multiple brain arteriovenous malformations
* Brain arteriovenous malformation complicated with blood flow-related aneurysm that may require staged and delayed treatment using other methods within the one-year follow-up period
* Brain arteriovenous malformation with a history of stereotactic radiosurgery within 3 years
* Brain arteriovenous malformation with bleeding within 1 week
* Brain arteriovenous malformation with an expected number of embolizations ≥ 4
* Brain arteriovenous malformation scheduled for surgical resection after embolization
* mRS score ≥ 3
* Subjects unsuitable for anesthesia or endovascular surgical treatment, due to major diseases of cardio, lung, liver, spleen or kidney, malignant brain tumors, severe active infection, disseminated intravascular coagulation, or a history of severe mental illness, etc
* Subjects who undergo major surgical procedures (such as tumor resection, vital organ surgery, etc.) within 30 days prior to signing the informed consent form, or those scheduled for such procedures within 60 days after signing the informed consent form
* Contraindications for liquid embolic agent treatment, including but not limited to: contraindications for DSA, severe allergy or intolerance to contrast agents, severe allergy or intolerance to antiplatelet or anticoagulant medications required for treatment, or severe allergy to tantalum metal
* Pregnant or lactating women
* Subjects participating in other drug or device studies that have not reached their endpoints or who have just withdrawn from the group for less than one month

Where it's running

• Shanghai Changhai Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Liu Shugen
• Email: Shugen.Liu@microport.com
• Phone: 18353892888

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.