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Study on the Effectiveness and Safety of Coil System for Intracranial Aneurysm Embolization

Intracranial Aneurysm Clinical Trial

Official title:
Study on the Effectiveness and Safety of Coil System for Intracranial Aneurysm Embolization

Clinical Trial Summary

"Study on the effectiveness and safety of the coil system for the treatment of intracranial aneurysms embolization" was sponsored by Zhuhai Tongqiao Medical Technology Co., Ltd. The trial design is: prospective, multi-center, randomized, open, parallel positive control, and non-inferiority test. Purpose: To compare the data obtained by using the coil system produced by Zhuhai Tongqiao Medical Technology Co., Ltd. and the Axium Detachable Coil produced by Medtronic for the embolization of intracranial aneurysms to evaluate the effectiveness and safety of coil system for intracranial aneurysms embolization.

Clinical Trial Description

"Study on the effectiveness and safety of the coil system for the treatment of intracranial aneurysms embolization" was sponsored by Zhuhai Tongqiao Medical Technology Co., Ltd. The team leader is Shanghai Changhai Hospital and the Second Affiliated Hospital of Zhejiang University School of Medicine. The trial design is: prospective, multi-center, randomized, open, parallel positive control, and non-inferiority test. Purpose: To compare the data obtained by using the coil system produced by Zhuhai Tongqiao Medical Technology Co., Ltd. and the Axium Detachable Coil produced by Medtronic for the embolization of intracranial aneurysms to evaluate the effectiveness and safety of coil system for intracranial aneurysms embolization. Sample: 228 cases. The subjects will be randomly assigned to the test group or the control group, with 114 cases in each group. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04497181
Study type Interventional
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact jianmin zhang, M.D.
Phone +86 0571 87784755
Email zjm135@zju.edu.cn
Status Recruiting
Phase N/A
Start date March 1, 2010
Completion date December 31, 2020
View Details
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