Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
Location status: Recruiting
Location contact
Li qiang
CONTACT
NCT Number: NCT07314047
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, China
Location status: Recruiting
Li qiang
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
liquid embolic agent
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
Time frame: 1 year after procedure
Favorable clinical outcome refers to a mRS score of ≥ 0 and ≤ 2
Time frame: 1 month after procedure
Time frame: 1 month after procedure
Time frame: 1 month after procedure
Time frame: 1 year after procedure
Contact information is provided by the study sponsor or research team.
MicroPort NeuroTech Co., Ltd.
Industry
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
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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