Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04497181
Status:
UNKNOWN
Last Update Posted:
2020-08-04
First Post:
2020-07-26
Brief Title:
Study on the Effectiveness and Safety of Coil System for Intracranial Aneurysm Embolization
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
Study on the Effectiveness and Safety of Coil System for Intracranial Aneurysm Embolization
Status:
UNKNOWN
Status Verified Date:
2020-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None