The Liquid Embolic Agent for the Treatment of Brain Arteriovenous Malformation

NCT07314047 | Recruiting

• 1 other identifier: LAVA-2023-01-CIP-00
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Brain Arteriovenous Malformation; Arteriovenous Fistula

Keywords

brain arteriovenous malformation; arteriovenous fistula; LIQUID EMBOLIC AGENT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  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

Study Arms (2)

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.

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.

Device: liquid embolic agent

Interventions

liquid embolic agent DEVICE

liquid embolic agent

Liquid embolic agent; the Onyx Liquid Embolic System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MicroPort NeuroTech Co., Ltd.: lead

Study Sites (1)

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Liu Shugen

CONTACT

18353892888; Shugen.Liu@microport.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Model Description

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 2, 2026
• Study Start: May 28, 2024
• Primary Completion: May 28, 2025
• Study Completion (Estimated): May 28, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

CN (1)