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NCT Number: NCT07314047

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

Li qiang

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liquid embolic agent

Device

liquid embolic agent

Primary outcomes

  1. 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

Secondary outcomes

  1. Rate of favorable clinical outcomes during the 1 year follow-up period

    Time frame: 1 year after procedure

    Favorable clinical outcome refers to a mRS score of ≥ 0 and ≤ 2

  2. Incidence of symptomatic stroke or death within one month after procedure

    Time frame: 1 month after procedure

  3. Incidence of symptomatic intracranial hemorrhage related to procedure within 1 month after procedure

    Time frame: 1 month after procedure

  4. Incidence of symptomatic ischemic stroke related to procedure within 1 month after procedure

    Time frame: 1 month after procedure

  5. Incidence of device-related serious adverse events during the 1 year follow-up period

    Time frame: 1 year after procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Liu Shugen

CONTACT

[email protected]

18353892888

Sponsors and collaborators

Lead sponsor

MicroPort NeuroTech Co., Ltd.

Industry

Registry information

Official study 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

Acronym: PARTNER

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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