Safety and Efficacy of Stent Deployment for Intracranial Aneurysms (SESIA)
NCT03387995 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4157
Last updated 2024-09-23
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.
Conditions
- Treatment Outcome by Stent-assisted Embolization
Interventions
- DEVICE
-
LVIS stent
The paitents treated by LVIS stent implantation.
- DEVICE
-
Solitaire stent
The paitents treated by Solitaire stent implantation.
- DEVICE
-
Enterprise stent
The paitents treated by Enterprise stent implantation.
- DEVICE
-
Neuroform stent
The paitents treated by Neuroform stent implantation.
- DEVICE
-
Flow diverter (FD) stent
The paitents treated by Enterprise FD implantation.
Sponsors & Collaborators
-
Nanfang Hospital, Southern Medical University
collaborator OTHER -
Guangdong Provincial People's Hospital
collaborator OTHER -
Beijing Tiantan Hospital
collaborator OTHER -
First Affiliated Hospital of Chongqing Medical University
collaborator OTHER -
The Affiliated Hospital Of Southwest Medical University
collaborator OTHER -
Guangdong 999 Brain Hospital
collaborator OTHER -
Eighth Affiliated Hospital, Sun Yat-sen University
collaborator OTHER -
Zhujiang Hospital
lead OTHER
Principal Investigators
-
Chuanzhi Duan, Ph.D. · Department of Neurosurgery, Zhujiang Hospital,Southern Medical University
Eligibility
- Min Age
- 14 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-09-01
- Primary Completion
- 2023-12-30
- Completion
- 2024-08-30
Countries
- China
Study Locations
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