Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

4,157

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Sep 2016

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

8 years study duration

Study Start

First participant enrolled

September 1, 2016

Completed

1.2 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2017

Completed

1 month until next milestone

First Posted

Study publicly available on registry

January 2, 2018

Completed

6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed

8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed

Last Updated

September 23, 2024

Status Verified

September 1, 2024

Enrollment Period

7.3 years

First QC Date

November 27, 2017

Last Update Submit

September 19, 2024

Conditions

Treatment Outcome by Stent-assisted Embolization

Keywords

treatment outcome

Outcome Measures

Primary Outcomes (5)

The safety evaluation of interventional therapy
Modified Rankin Scale (mRS) score to measure the safety of of interventional therapy
6 months later after operation
The efficacy evaluation of interventional treatment
Raymond-Ray scale (for common stent) and O'Kelley Morrota scale (for FD) to measure the effectiveness of interventional treatment
6 months later after operation
Evaluate the relationship between intracranial aneurysm and cyclin dependent
The investigators will take the participant's blood and the relationship between intracranial aneurysm and CDKN2BAS1 will be evaluated by ligase detection reaction-polymerase chain reaction(LDP-PCR)
6 months later after operation
The cerebrovascular complication after interventional therapy
Perioperative and delayed cerebrovascular complication after stent deployment
6 months later after operation
The incidence of in-stent stenosis after stent deployment
the rate and degree of in-stent stenosis after stent deployment
6 months later after operation