NCT05524285

Safety Study of Intracranial Support Catheter and Guide Catheter for Stent-Assisted Embolization in the Treatment of Intracranial Aneurysms

Safety Study of Intracranial Support Catheter and Guide Catheter for Stent-Assisted Embolization in the Treatment of Intracranial Aneurysms: A Prospective, Multicenter, Randomized, Open, Controlled, Superiority Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety differences between intracranial support catheter and guide catheter for stent-assisted embolization in the treatment of unruptured intracranial aneurysms in the anterior circulation.

Detailed description

This is a prospective, multicenter, randomized, open, controlled, superiority trial carried out in 9 research centers over China. Patients are randomized 1:1 to therapy either intracranial support catheter or guide catheter. Taking the guide catheter as a control, to evaluate whether the safety of intracranial support catheter for stent-assisted embolization in the treatment of unruptured intracranial aneurysms in the anterior circulation is superior than that of the control.

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
DEVICE	Intracranial Support Catheter	Endovascular procedure using the intracranial support catheter which approved by NMPA
DEVICE	Guide Catheter	Endovascular procedure using the guide catheter which approved by NMPA

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-10-01
• Completion: 2024-03-01
• First posted: 2022-09-01
• Last updated: 2023-02-09

Locations

9 sites across 1 country: China