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Bioabsorbable/Nufairy Coil Application Trial in China — NuCATCH  

Intracranial Aneurysm Clinical Trial

Official title:
A Prospective, Multi-center, Open-label, Non-inferiority, Randomized, Controlled Trial of Bioabsorbable/Nufairy Coil Embolization System for the Treatment of Intracranial Aneurysms

Clinical Trial Summary

The scope of this trial is the collection and analysis of effectiveness and safety endpoints, related to the use of the Bioabsorbable/Nufairy Coil Embolization System in the treatment of intracranial aneurysms.

Clinical Trial Description

Approximately 258 subjects with intracranial aneurysms would be enrolled for coiling embolization according to the inclusion and exclusion criteria specified in this trial protocol. Subjects were evaluated by mRS preoperatively, at the time of device implantation, at the time of discharge from the hospital, at 1 month (±7 days) postoperatively, at 6 months (±30 days) postoperatively, and at 12 months (±90 days) postoperatively; subjects would underwent DSA imaging at surgery and at 12months (±90 days) postoperatively, and MRA imaging at 18 months (±90 days) postoperatively. Unplanned follow-up of the subjects would performed when necessary, and data would be recorded to evaluate the safety and efficacy of Nufairy Coil Embolization System for coiling embolization for the treatment of intracranial aneurysms. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06466564
Study type Interventional
Source MicroPort NeuroTech Co., Ltd.
Contact
Status Active, not recruiting
Phase N/A
Start date December 24, 2023
Completion date June 1, 2026
View Details
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