NCT06303063

Compare the Safety and Effectiveness of Two Different Kinds of Stent System in Intracranial Aneurysms

A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Safety and Effectiveness of the SINOMED IAS for the Treatment of Intracranial Aneurysms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Sinomed Neurovita Technology Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IAS in patients with intracranial aneurysms.

Detailed description

This study is a prospective, multicenter, 1:1 randomized clinical trial to evaluate the safety and efficacy of stent system in the treatment of intracranial aneurysms. A total of 204 patients are planned to be included. The primary endpoint is the incidence of success aneurysm occlusion at 6-month post procedure. All patients will have clinical follow-up during intraoperative, 30 days, 6 months, 1 year.

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
DEVICE	SINOMED IAS Stent System	Stent-assisted coiling (SAC) of intracranial aneurysms paved the way for endovascular coiling of wide-neck aneurysms, improving rates of aneurysm obliteration and recurrence.
DEVICE	Neuroform Atlas Stent System	Stent-assisted coiling (SAC) of intracranial aneurysms paved the way for endovascular coiling of wide-neck aneurysms, improving rates of aneurysm obliteration and recurrence.

Timeline

• Start date: 2024-01-17
• Primary completion: 2025-11-20
• Completion: 2025-11-20
• First posted: 2024-03-12
• Last updated: 2026-03-17

Locations

1 site across 1 country: China