NCT06479343

Efficacy and Safety of the Liquid Embolic System (Tonbridge) for Endovascular Treatment of Cerebrovascular Malformations

Efficacy and Safety of the Liquid Embolic System (Tonbridge) for Endovascular Treatment of Cerebrovascular Malformations: a Prospective, Multi-center, Randomized, Parallel Positive Controlled, Non-inferiority Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Ton-Bridge Medical Tech. Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to verify the efficacy and safety of the Liquid Embolic System (Tonbridge Medical Tech. Co., Ltd. (Suzhou)) for the treatment of cerebrovascular malformations.

Detailed description

This is a prospective, multi-center, randomized, parallel positive controlled, non-inferiority trial. This clinical trial is conducted at more than 2 centers in China, and patients who intend to be treated with liquid embolic system for cerebrovascular malformations are enrolled. Eligible patients are randomized into experimental group using Liquid Embolic System (Tonbridge) or control group using Onyx Liquid Embolic System (Medtronic) in a 1:1 ratio. The purpose of this study is to evaluate the effectiveness and safety of the Liquid Embolic System (Tonbridge).

Conditions

• Intracranial Arteriovenous Malformations

Interventions

Type	Name	Description
DEVICE	Liquid Embolic System (Tonbridge)	Endovascular treatment with Liquid Embolic System (Tonbridge).
DEVICE	Onyx Liquid Embolic System (Medtronic)	Endovascular treatment with Onyx Liquid Embolic System (Medtronic).

Timeline

• Start date: 2024-06-27
• Primary completion: 2025-10-01
• Completion: 2026-10-01
• First posted: 2024-06-28
• Last updated: 2024-09-19

Locations

14 sites across 1 country: China