CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 4,157 enrolled
Drug / intervention
LVIS stent +4 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03387995
NCT03387995N/ACompleted

Safety and Efficacy of Stent Deployment for Intracranial Aneurysms: Trials of Clinical Curative Effect, Follow-up Study and Hemodynamics

Zhujiang Hospital·observational·Posted Jan 2, 2018·Updated Sep 23, 2024

In Brief

An observational study evaluating LVIS stent, Solitaire stent, and 3 other interventions for Treatment Outcome by Stent-assisted Embolization. Completed, enrolled 4,157 participants across 1 site.

Detailed Summary

Intracranial aneurysms (IA) regarded the third cause of cerebral vascular disease is the majoy cause of subarachnoid hemorrhage (SAH). The mortality and morbidity account for 22% to 25% in cerebrovascular disease. More than half of the ruptured IA survivors has serious nerve dysfunction such as hemiplegia, aphasia,which seriously harms to human health. Endovascular embolization is one of the main treatment ways of IA.However,there are no studies on the multicenter cases of stent selection strategy at home and abroad.Therefore, the investigators conduct a prospective study by comparing the clinical efficacy, follow-up results, and hemodynamics between preoperative and postoperative patients with different types of stent assisted embolization treatment of IA.The investigators also study the relationship between cyclin dependent kinase inhibitor 2B antisense RNA 1 gene(CDKN2BAS1 gene)of IA patients and the results, for making indication of stents, improving the cure rate, reducing the recurrence rate of IA patients, providing theory gist for interventional therapy of complex IA and simplying slection of stent.

Study Details

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 2, 2018
Enrollment StartSep 1, 2016
Primary CompletionDec 30, 2023
Study CompletionAug 30, 2024
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 8.5 years ago

Interventions

LVIS stentdevice

The paitents treated by LVIS stent implantation.

Solitaire stentdevice

The paitents treated by Solitaire stent implantation.

Enterprise stentdevice

The paitents treated by Enterprise stent implantation.

Neuroform stentdevice

The paitents treated by Neuroform stent implantation.

Flow diverter (FD) stentdevice

The paitents treated by Enterprise FD implantation.