The Efficacy and Safety Study on Endovascular Embolization of Intracranial Aneurysms With Coil System(Ton-bridgeMT)

Zhuhai Tonbridge Medical Tech. Co., Ltd.12 sites in 1 country256 target enrollmentMay 28, 2018

ConditionsIntracranial Aneurysms

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intracranial Aneurysms
Sponsor: Zhuhai Tonbridge Medical Tech. Co., Ltd.
Enrollment: 256
Locations: 12
Primary Endpoint: success rate of occlusion
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study is a prospective, multi-center, randomized, open, parallel positive control, non-inferiority trial. Patients are randomized 1:1 to either Coil System(Ton-bridgeMT) or Axium Detachable Coil(Medtronic).

The purpose of this study is to assess the safety and effectiveness of the Coil System(Ton-bridgeMT) in the treatment of intracranial aneurysms.

Registry

clinicaltrials.gov

Start Date

May 28, 2018

End Date

September 2, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zhuhai Tonbridge Medical Tech. Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18-80 years.
•Subject has a target intracranial aneurysm (IA) diagnosed by DSA, and intended to be embolised with coil system.
•Subject or guardian is able to understand the purpose of study, agrees to comply with protocol requirements and has provided written informed consent.

Exclusion Criteria

•Subject is diagnosed as multiple aneurysms.
•Subject is diagnosed as intracranial bulloid, fusiform, false, dissectimng, infective aneurysm or with arteriovenous malformation.
•mRS score≥
•Hunt and Hess classification≥
•Subject has emergency ruptured aneurysms and needs assisting stent.
•The target aneurysm has received endovascular embolization or surgical treatment.
•The aneurysm carrier artery has severe stenosis.
•PLT\<60×109/L or INR\>1.
•Subject has nonfunction of important organs or other severe diseases.
•Major surgery in the last 30 days, or intending to receive surgical treatment in 90 days after enrollment.