NCT05774782

Parent Artery Reconstruction for Cerebral Aneurysms Using a Novel Flow Diverter With Surface Modification

A Prospective, Multi-center, Single Arm Clinical Study to Evaluate the Safety and Effectiveness of the Flow Diverter Stent System in the Treatment of Cerebral Aneurysms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Sinomed Neurovita Technology Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this trial is to evaluate the safety and efficacy of the cerebral flow diverter in the endovascular treatment of wide-necked cerebral aneurysms

Detailed description

The investigation is a prospective, multi-center, single arm clinical study. The trial is anticipated to last from March 2023 to January 2025 with 143 subjects recruited in around 10 China centers. The population for this study is subjects with wide-necked intracranial aneurysms who are suitable candidates for flow diverter implantation. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be enrolled after offering informed consent form. The study consists of six visits including preoperative screening, operation date, 7days or at discharge, 30 days, 180 days, and 1 year. The primary efficacy endpoint was complete aneurysm occlusion with parent artery stenosis ≤ 50% at one year post-procedure in the absence of additional treatments, while the primary safety endpoint was no major stroke in the treated artery territory or neurological death at one year post-procedure.

Conditions

• Cerebral Aneurysm
• Cerebral Aneurysm Unruptured

Interventions

Type	Name	Description
DEVICE	Cerebral flow diverter	The surface-modified flow diverter is an intracranial implant designed to be placed in a parent artery so as to divert blood flow away from an aneurysm.

Timeline

• Start date: 2023-03-27
• Primary completion: 2024-06-23
• Completion: 2024-08-30
• First posted: 2023-03-20
• Last updated: 2026-01-26

Locations

1 site across 1 country: China