NCT03387995: SESIA

Safety and Efficacy of Stent Deployment for Intracranial Aneurysms (SESIA)

Completed Last updated 23 September 2024

What this trial tests

trial testing LVIS stent in Treatment Outcome by Stent-assisted Embolization in 4,157 participants. Completed in 30 August 2024.

Timeline

1 September 2016

Primary endpoint
30 December 2023

30 August 2024

Quick facts

Lead sponsor	Zhujiang Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	4,157
Start date	1 September 2016
Primary completion	30 December 2023
Estimated completion	30 August 2024
Sites	1 location across China

Drugs / interventions tested

• LVIS stent
• Solitaire stent
• Enterprise stent
• Neuroform stent
• Flow diverter (FD) stent

Conditions studied

• Treatment Outcome by Stent-assisted Embolization — all drugs for Treatment Outcome by Stent-assisted Embolization →

Sponsor

Zhujiang Hospital

Who can join

Adults 14 to 80, any sex, with Treatment Outcome by Stent-assisted Embolization. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of LDL-Cholesterol Levels and Oral Atorvastatin on Outcomes After Pipeline Therapy for Intracranial Aneurysms.
   Feng X, Huang C, Tong X, Wen Z, et al · · 2025 · cited 1× · PMID 40765506 · DOI 10.1161/strokeaha.124.049833