The Liquid Embolic Agent for the Treatment of Brain Arteriovenous Malformation (PARTNER)

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.

Study Overview

• Status: Recruiting
• Conditions: Arteriovenous Fistula; Brain Arteriovenous Malformation
• Intervention / Treatment: Device: liquid embolic agent

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liu Shugen; Phone Number: 18353892888; Email: Shugen.Liu@microport.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Recruiting
      • Shanghai Changhai Hospital
      • Contact: Li qiang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liquid embolic agent; Liquid embolic agent developed and manufactured by MicroPort NeuroTech.Liquid embolic agents are used to embolize cerebrovascular malformations during the procedure.	Device: liquid embolic agent; liquid embolic agent
Active Comparator: the Onyx Liquid Embolic System; 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.	Device: liquid embolic agent; liquid embolic agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Perioperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of favorable clinical outcomes during the 1 year follow-up period	Favorable clinical outcome refers to a mRS score of ≥ 0 and ≤ 2	1 year after procedure
Incidence of symptomatic stroke or death within one month after procedure		1 month after procedure
Incidence of symptomatic intracranial hemorrhage related to procedure within 1 month after procedure		1 month after procedure
Incidence of symptomatic ischemic stroke related to procedure within 1 month after procedure		1 month after procedure
Incidence of device-related serious adverse events during the 1 year follow-up period		1 year after procedure

Collaborators and Investigators

• Sponsor: MicroPort NeuroTech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2024
• Primary Completion (Actual): May 28, 2025
• Study Completion (Estimated): May 28, 2026

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: arteriovenous fistula; brain arteriovenous malformation; LIQUID EMBOLIC AGENT
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Fistula; Arteriovenous Malformations; Vascular Fistula; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Arteriovenous Fistula
• Other Study ID Numbers: LAVA-2023-01-CIP-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: To be decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No