NCT06189950

Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms:REBRIDGE

a Prospective, Multi-center, Open-label, Non-inferiority, Randomized, Controlled Registration Trial of the Intracranial Stent for the Treatment of Intracranial Aneurysms: Rebridge

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: MicroPort NeuroTech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This trial was designed as a prospective, multicentre, open, non-inferiority, randomised controlled clinical trial, with the control devices being MicroVention's LVIS Intraluminal Support Device and LVIS Jr. Intraluminal Support Device. Approximately 200 subjects with intracranial aneurysms would be enrolled for stent-assisted coiling embolisation 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 (±60 days) postoperatively; subjects would underwent DSA imaging at surgery and at 6 months (±30 days) postoperatively, and MRA or DSA imaging at 12 months (±60 days) postoperatively. Unplanned follow-up of the subjects would performed when necessary, and data would be recorded to evaluate the safety and efficacy of intracranial artery stent for stent-assisted coiling embolisation for the treatment of intracranial aneurysms.

Conditions

• Brain Diseases
• Aneurysm
• Intracranial Aneurysm

Interventions

Type	Name	Description
DEVICE	Intracranial stent for wide-necked aneurysms	Intracranial stent for wide-necked aneurysms

Timeline

• Start date: 2023-10-30
• Primary completion: 2025-10-30
• Completion: 2026-10-30
• First posted: 2024-01-05
• Last updated: 2024-01-05

Locations

1 site across 1 country: China