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

Cerebral Aneurysm Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial 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 endpoint is success aneurysm occlusion at 1 year post procedure. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05774782
Study type Interventional
Source Sinomed Neurovita Technology Inc.
Contact
Status Active, not recruiting
Phase N/A
Start date March 27, 2023
Completion date January 2025
View Details
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