NCT06466564

Bioabsorbable/Nufairy Coil Application Trial in China

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 258 (estimated)
• Sponsor: MicroPort NeuroTech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
DEVICE	Nufairy® Coil embolization system for intracranial aneurysm	Nufairy® Coil embolization system for intracranial aneurysm

Timeline

• Start date: 2023-12-24
• Primary completion: 2025-10-31
• Completion: 2026-06-01
• First posted: 2024-06-20
• Last updated: 2024-06-20

Locations

1 site across 1 country: China