NCT06158087

To Evaluate the Safety and Efficacy of Intracranial Stent Assisted Endovascular Treatment of Intracranial Aneurysms

Prospective, Multicenter, Single-arm Clinical Trial to Evaluate the Safety and Efficacy of pEGASUS Stent System for Assisted Endovascular Treatment of Intracranial Aneurysms

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Shanghai Wallaby Medical Technologies Co.,Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess safety and effectiveness of the pEGASUS stent system.

Detailed description

Title: A prospective, multicenter, single-arm clinical trial to evaluate the safety and efficacy of pEGASUS stent system for assisted endovascular treatment of intracranial aneurysms Device: pEGASUS stent system Design: Prospective, Multicenter, Single Arm Clinical Study. Purpose: To assess safety and effectiveness of the pEGASUS stent system. Study duration: 31 months. Sample Size: 130 patients. Number of sites: ≤10. Follow-up time: 12 months.

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
DEVICE	pEGASUS Stent System	Endovascular intervention with p64/p48 MW HPC pEGASUS Stent System was performed in patients diagnosed with intracranial aneurysms

Timeline

• Start date: 2023-12-29
• Primary completion: 2026-02-20
• Completion: 2026-06-20
• First posted: 2023-12-06
• Last updated: 2024-06-27

Locations

1 site across 1 country: China