Safety and Efficacy of Stent Deployment for Intracranial Aneurysms (SESIA)
NCT ID: NCT03387995
Last Updated: 2024-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
4157 participants
OBSERVATIONAL
2016-09-01
2024-08-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment of Ruptured Intracranial Aneurysms in China.
NCT03462433
Stent Implantation Versus Balloon Dilation for Acute Anterior Circulation Tandem Occlusion
NCT05902000
Balloon Angioplasty for Symptomatic Intracranial Artery Stenosis
NCT03703635
Hemodynamic Analysis for Intracranial Aneurysms Recanalization After Endovascular Treatment
NCT02812108
Parent Artery Reconstruction for Cerebral Aneurysms Using a Novel Flow Diverter With Surface Modification
NCT05774782
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
There are many kinds intracranial stents for clinical surgery, but how to choose the appropriate stent type is one of the key issues that clinicians need to settle. And, there is no relevant multicenter cases study about selection strategy of intracranial stent at home and abroad.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Anterior communicating artery aneurysm
Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
LVIS stent
The paitents treated by LVIS stent implantation.
Solitaire stent
The paitents treated by Solitaire stent implantation.
Enterprise stent
The paitents treated by Enterprise stent implantation.
Neuroform stent
The paitents treated by Neuroform stent implantation.
Flow diverter (FD) stent
The paitents treated by Enterprise FD implantation.
Middle cerebral artery aneurysm
Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
LVIS stent
The paitents treated by LVIS stent implantation.
Solitaire stent
The paitents treated by Solitaire stent implantation.
Enterprise stent
The paitents treated by Enterprise stent implantation.
Neuroform stent
The paitents treated by Neuroform stent implantation.
Flow diverter (FD) stent
The paitents treated by Enterprise FD implantation.
Posterior communicating artery aneurysm
Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
LVIS stent
The paitents treated by LVIS stent implantation.
Solitaire stent
The paitents treated by Solitaire stent implantation.
Enterprise stent
The paitents treated by Enterprise stent implantation.
Neuroform stent
The paitents treated by Neuroform stent implantation.
Flow diverter (FD) stent
The paitents treated by Enterprise FD implantation.
Internal carotid artery aneurysm
Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
LVIS stent
The paitents treated by LVIS stent implantation.
Solitaire stent
The paitents treated by Solitaire stent implantation.
Enterprise stent
The paitents treated by Enterprise stent implantation.
Neuroform stent
The paitents treated by Neuroform stent implantation.
Flow diverter (FD) stent
The paitents treated by Enterprise FD implantation.
Vertebrobasilar system aneurysms
Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.
LVIS stent
The paitents treated by LVIS stent implantation.
Solitaire stent
The paitents treated by Solitaire stent implantation.
Enterprise stent
The paitents treated by Enterprise stent implantation.
Neuroform stent
The paitents treated by Neuroform stent implantation.
Flow diverter (FD) stent
The paitents treated by Enterprise FD implantation.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LVIS stent
The paitents treated by LVIS stent implantation.
Solitaire stent
The paitents treated by Solitaire stent implantation.
Enterprise stent
The paitents treated by Enterprise stent implantation.
Neuroform stent
The paitents treated by Neuroform stent implantation.
Flow diverter (FD) stent
The paitents treated by Enterprise FD implantation.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Subject has accepted stent - assisted embolization or flow-diversion treatment of intracranial aneurysm
Exclusion Criteria
* Subject has received previous surgical clipping or endovascular treatment
* Subject has no intracranial aneurysms by DSA
* Subject with poor image quality
* Subject cannot use stent because of the small parent artery
* Subject do not need to use stent because of narrow-neck aneurysm
* History of aneurysm
14 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nanfang Hospital, Southern Medical University
OTHER
Guangdong Provincial People's Hospital
OTHER
Beijing Tiantan Hospital
OTHER
First Affiliated Hospital of Chongqing Medical University
OTHER
The Affiliated Hospital Of Southwest Medical University
OTHER
Guangdong 999 Brain Hospital
OTHER
Eighth Affiliated Hospital, Sun Yat-sen University
OTHER
Zhujiang Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Duan Chuanzhi
Neurovascular Center of Zhujiang Hospital
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chuanzhi Duan, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Neurosurgery, Zhujiang Hospital,Southern Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ZhuJiang Hospital,Southern Medical University
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Zhang X, Long XA, Luo B, Karuna T, Duan CZ. Factors responsible for poor outcome after intraprocedural rerupture of ruptured intracranial aneurysms: identification of risk factors, prevention and management on 18 cases. Eur J Radiol. 2012 Jan;81(1):e77-85. doi: 10.1016/j.ejrad.2011.02.015. Epub 2011 Feb 24.
Standhardt H, Boecher-Schwarz H, Gruber A, Benesch T, Knosp E, Bavinzski G. Endovascular treatment of unruptured intracranial aneurysms with Guglielmi detachable coils: short- and long-term results of a single-centre series. Stroke. 2008 Mar;39(3):899-904. doi: 10.1161/STROKEAHA.107.496372. Epub 2008 Feb 7.
Ishibashi T, Murayama Y, Urashima M, Saguchi T, Ebara M, Arakawa H, Irie K, Takao H, Abe T. Unruptured intracranial aneurysms: incidence of rupture and risk factors. Stroke. 2009 Jan;40(1):313-6. doi: 10.1161/STROKEAHA.108.521674. Epub 2008 Oct 9.
Gu DQ, Zhang X, Luo B, Long XA, Duan CZ. The effect of Neuroform stent-assisted coil embolization of wide-necked intracranial aneurysms and clinical factors on progressive aneurysm occlusion on angiographic follow-up. J Clin Neurosci. 2013 Feb;20(2):244-7. doi: 10.1016/j.jocn.2012.01.053. Epub 2012 Nov 30.
Ye HW, Liu YQ, Wang QJ, Zheng T, Cui XB, Gao YY, Lai LF, Zhang X, Li XF, Su SX, He XY, Duan CZ. Comparison between Solitaire AB and Enterprise stent-assisted coiling for intracranial aneurysms. Exp Ther Med. 2015 Jul;10(1):145-153. doi: 10.3892/etm.2015.2481. Epub 2015 May 8.
Li H, He XY, Li XF, Zhang X, Liu YC, Duan CZ. Treatment of giant/large internal carotid aneurysms: parent artery occlusion or stent-assisted coiling. Int J Neurosci. 2016;126(1):46-52. doi: 10.3109/00207454.2014.992427. Epub 2015 Jan 7.
Naggara ON, White PM, Guilbert F, Roy D, Weill A, Raymond J. Endovascular treatment of intracranial unruptured aneurysms: systematic review and meta-analysis of the literature on safety and efficacy. Radiology. 2010 Sep;256(3):887-97. doi: 10.1148/radiol.10091982. Epub 2010 Jul 15.
Mitra D, Herwadkar A, Soh C, Gholkar A. Follow-up of intracranial aneurysms treated with matrix detachable coils: a single-center experience. AJNR Am J Neuroradiol. 2007 Feb;28(2):362-7.
Lopes D, Sani S. Histological postmortem study of an internal carotid artery aneurysm treated with the Neuroform stent. Neurosurgery. 2005 Feb;56(2):E416; discussion E416. doi: 10.1227/01.neu.0000147977.07736.66.
Feng X, Huang C, Tong X, Wen Z, Zhu Y, Huang M, Lin J, Huang J, Yuan H, Xu A, Ma G, Ge R, Li C, Peng C, Su S, Zhang X, Li X, Guo Z, Liu A, Duan C. Effect of LDL-Cholesterol Levels and Oral Atorvastatin on Outcomes After Pipeline Therapy for Intracranial Aneurysms. Stroke. 2025 Oct;56(10):3002-3013. doi: 10.1161/STROKEAHA.124.049833. Epub 2025 Aug 6.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LC2016ZD024
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.