Liquid embolic treatment for brain arteriovenous malformations
a Prospective, Multi-center, Open-label, Non-inferiority, Randomized, Controlled Registration Trial of the Liquid Embolic Agent for the Treatment of Brain Arteriovenous Malformation
This study will test a new liquid embolic agent against the Onyx system in adults (18–80) with brain arteriovenous malformations to see if it is as safe and effective.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | MicroPort NeuroTech Co., Ltd. Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT07314047 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18–80 with a single brain arteriovenous malformation classified Spetzler‑Martin I–IV, judged suitable for liquid embolization, and able to give informed consent are the intended participants.
Not a fit: Patients with multiple AVMs, recent bleeding (within 1 week), prior stereotactic radiosurgery within 3 years, AVMs with flow‑related aneurysms requiring staged treatment, or those outside the 18–80 age range are unlikely to qualify or benefit from this protocol.
Why it matters
Potential benefit: If successful, the device could provide an alternative liquid embolic option with similar safety and effectiveness to Onyx, broadening treatment choices for patients.
How similar studies have performed: Other liquid embolic agents such as Onyx have an established record of clinical use and effectiveness for AVM embolization, so the general approach is established though this specific device is being tested for comparable performance.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Shanghai Changhai Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Liu Shugen
- Email: Shugen.Liu@microport.com
- Phone: 18353892888
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.