Brain Arteriovenous MalformationPARTNERNCT07314047
The Liquid Embolic Agent for the Treatment of Brain Arteriovenous Malformation
A study testing liquid embolic agent in people with Brain Arteriovenous Malformation and Arteriovenous Fistula, run by MicroPort NeuroTech Co., Ltd. at 1 site in China.
Trial summary
This study is designed as a prospective, multi-center, open-label, non-inferiority, randomized controlled clinical trial. The control device is Onyx Liquid Embolic System marketed by Micro Therapeutics Inc. DBA ev3 Neurovascular (NMPA (J) 20173136690). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Arteriovenous Malformation, Arteriovenous Fistula
- What is being tested?
- liquid embolic agent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 28 May 2024to 28 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality
Li qiang
About this study
Official title: 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 is designed as a prospective, multi-center, open-label, non-inferiority, randomized controlled clinical trial. The control device is Onyx Liquid Embolic System marketed by Micro Therapeutics Inc. DBA ev3 Neurovascular (NMPA (J) 20173136690). According to the inclusion and exclusion criteria specified in this trial protocol, approximately 116 subjects with brain arteriovenous malformation will be enrolled for interventional embolization treatment. The subjects will undergo follow-up before the surgery, after device implantation, at discharge, 1 month (± 7 days), 6 months (± 30 days), and 12 months (± 60 days) after the first embolization. When necessary, unscheduled follow-up will be conducted to record various indicators for evaluating the safety and effectiveness of liquid embolic agents in the treatment of brain arteriovenous malformations.
- Being tested
- liquid embolic agent
- Keywords
- brain arteriovenous malformation, arteriovenous fistula, LIQUID EMBOLIC AGENT
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liquid embolic agentDevice
liquid embolic agent
| Study group | Role | What they receive |
|---|---|---|
| Liquid embolic agent | Experimental | Liquid embolic agent developed and manufactured by MicroPort NeuroTech.Liquid embolic agents are used to embolize cerebrovascular malformations during the procedure. Receives: Device: liquid embolic agent |
| the Onyx Liquid Embolic System | Active comparator | The Onyx Liquid Embolic System was developed and manufactured by Micro Therapeutics Inc. DBA ev3 Neurovascular. The Onyx Liquid Embolic System is used to embolize cerebrovascular malformations during the procedure. Receives: Device: liquid embolic agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of effective embolization of target brain arteriovenous malformation
Effective embolization refers to a reduction of ≥ 50% after the last embolization of the target brain arteriovenous malformation compared with that before the first embolization
Measured: Perioperative
Secondary outcomes (5)
Rate of favorable clinical outcomes during the 1 year follow-up period
Favorable clinical outcome refers to a mRS score of ≥ 0 and ≤ 2
Measured: 1 year after procedure
Incidence of symptomatic stroke or death within one month after procedure
Measured: 1 month after procedure
Incidence of symptomatic intracranial hemorrhage related to procedure within 1 month after procedure
Measured: 1 month after procedure
Incidence of symptomatic ischemic stroke related to procedure within 1 month after procedure
Measured: 1 month after procedure
Incidence of device-related serious adverse events during the 1 year follow-up period
Measured: 1 year after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start28 May 2024
- Primary completion28 May 2025
- Study completion28 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Arteriovenous MalformationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Model Description
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MicroPort NeuroTech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314047
- Sponsor's protocol ID
- LAVA-2023-01-CIP-00
- Acronym
- PARTNER
- Status last verified
- Dec 2025
- First submitted
- 16 Jan 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be decided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Prospective, Multi-center, Open-label, Non-inferiority, Randomized, Controlled Registration Trial of the Liquid Embolic Agent for the Treatment of Brain Arteriovenous Malformation
- ClinicalTrials.gov ID
- NCT07314047
- Acronym / sponsor ID
- PARTNER / LAVA-2023-01-CIP-00
- Keywords
- brain arteriovenous malformation, arteriovenous fistula, LIQUID EMBOLIC AGENT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- MicroPort NeuroTech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 May 2024 (actual)
- Primary completion
- 28 May 2025 (actual)
- Study completion
- 28 May 2026 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed as a prospective, multi-center, open-label, non-inferiority, randomized controlled clinical trial. The control device is Onyx Liquid Embolic System marketed by Micro Therapeutics Inc. DBA ev3 Neurovascular (NMPA (J) 20173136690). According to the inclusion and exclusion criteria specified in this trial protocol, approximately 116 subjects with brain arteriovenous malformation will be enrolled for interventional embolization treatment. The subjects will undergo follow-up before the surgery, after device implantation, at discharge, 1 month (± 7 days), 6 months (± 30 days), and 12 months (± 60 days) after the first embolization. When necessary, unscheduled follow-up will be conducted to record various indicators for evaluating the safety and effectiveness of liquid embolic agents in the treatment of brain arteriovenous malformations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Model Description
| Arm | Type | Receives |
|---|---|---|
| Liquid embolic agent | Experimental | Device: liquid embolic agentLiquid embolic agent developed and manufactured by MicroPort NeuroTech.Liquid embolic agents are used to embolize cerebrovascular malformations during the procedure. |
| the Onyx Liquid Embolic System | Active comparator | Device: liquid embolic agentThe Onyx Liquid Embolic System was developed and manufactured by Micro Therapeutics Inc. DBA ev3 Neurovascular. The Onyx Liquid Embolic System is used to embolize cerebrovascular malformations during the procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liquid embolic agentliquid embolic agent | Device | Liquid embolic agent, the Onyx Liquid Embolic System |
Primary outcome
Rate of effective embolization of target brain arteriovenous malformation
Time frame: Perioperative
Effective embolization refers to a reduction of ≥ 50% after the last embolization of the target brain arteriovenous malformation compared with that before the first embolization
5 secondary outcomes
Rate of favorable clinical outcomes during the 1 year follow-up period
Time frame: 1 year after procedure
Incidence of symptomatic stroke or death within one month after procedure
Time frame: 1 month after procedure
Incidence of symptomatic intracranial hemorrhage related to procedure within 1 month after procedure
Time frame: 1 month after procedure
Incidence of symptomatic ischemic stroke related to procedure within 1 month after procedure
Time frame: 1 month after procedure
Incidence of device-related serious adverse events during the 1 year follow-up period
Time frame: 1 year after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Undecided. To be decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing liquid embolic agent in people with Brain Arteriovenous Malformation and Arteriovenous Fistula, run by MicroPort NeuroTech Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liu Shugen (18353892888, Shugen.Liu@microport.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of effective embolization of target brain arteriovenous malformation (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.