NCT05058482

Non-adhesive Liquid Embolic System in the Embolization of Cerebral Arteriovenous Malformations

A Prospective, Multi-center, Randomized Parallel Controlled Study on the Safety and Effectiveness of the Non-adhesive Liquid Embolic System in the Embolization of Cerebral Arteriovenous Malformations

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Suzhou Hengruihongyuan Medical Technology Co. LTD · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is to verify the safety and effectiveness of the Non-adhesive Liquid Embolic System(NALES) produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. in the process of clinical use to support the application of the National Medical Products Administration ( NMPA) product registration approval.

Detailed description

A prospective, multicenter, randomized controlled trial was used in this study. Onyx Liquid Embolic System and Marathon Flow Directed Micro Catheter, which were registered and marketed in China and had good effect in the industry, were selected as the control devices. Subjects requiring cerebral arteriovenous malformation embolization were selected to participate in the trial based on pathological conditions and inclusion/exclusion criteria, and the use of test products or control products was determined based on central randomized results. Imaging data involving the main evaluation criteria were evaluated uniformly by the blind evaluators of the leading unit, so as to reduce the bias caused by subjective factors of different evaluators.

Conditions

• Intracranial Arteriovenous Malformations

Interventions

Type	Name	Description
DEVICE	embolism	Cerebral arteriovenous malformation embolism

Timeline

• Start date: 2021-12-02
• Primary completion: 2023-10-17
• Completion: 2024-10-17
• First posted: 2021-09-27
• Last updated: 2022-05-06

Locations

13 sites across 1 country: China