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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liquid embolic agent | Device | liquid embolic agent |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liu Shugen | Contact | 18353892888 | Shugen.Liu@microport.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Changhai Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
To be decided
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| ID | Term |
|---|---|
| D001164 | Arteriovenous Fistula |
| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
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Model Description
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Masking Description
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| 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 |
| D016157 | Vascular Fistula |
| D014652 | Vascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |