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

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

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 Overview

• Status: Completed
• Conditions: Treatment Outcome by Stent-assisted Embolization
• Intervention / Treatment: Device: LVIS stent; Device: Solitaire stent; Device: Enterprise stent; Device: Neuroform stent; Device: Flow diverter (FD) stent

Detailed Description

Studies showed 3.6% - 6% for the incidence and 1% - 2% for the ruptctued rate of IA.The mortality and morbidity account for 22% to 25% in cerebrovascular disease ,which is a growing trend. IA is one of the major diseases which relate with people's living standards. Endovascular embolization is one of the main treatments of IA with less invasive, Better cure rates and higher safety. It has been developed rapidly and improve quality of patients' lives after treatmen.With the rapid development of neural intervention and the proliferation of specialized stents in IA, stent-assisted embolization technique is becoming more and more common .Especially, stents play an important role in intracranial aneurysmal aneurysm.

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.

• Study Type: Observational
• Enrollment (Actual): 4157

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510282
      • Zhujiang Hospital,Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subject has intracranial aneurysms confirmed by CT arteriography (CTA) or magnetic resonance angiography (MRA) or digital subtraction angiography (DSA).

Description

Inclusion Criteria:

• Subject has intracranial aneurysms confirmed by CT arteriography (CTA) or magnetic resonance angiography (MRA) or digital subtraction angiography(DSA)
• Subject has accepted stent - assisted embolization or flow-diversion treatment of intracranial aneurysm

Exclusion Criteria:

• Subject has secondary intracranial aneurysms(e.g.traumatic aneurysm, infected aneurysm)
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anterior communicating artery aneurysm; Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.	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.
Middle cerebral artery aneurysm; Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.	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.
Posterior communicating artery aneurysm; Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.	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.
Internal carotid artery aneurysm; Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.	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.
Vertebrobasilar system aneurysms; Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The safety evaluation of interventional therapy	Modified Rankin Scale (mRS) score to measure the safety of of interventional therapy	24 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	24 months later after operation
The cerebrovascular complication after interventional therapy	Delayed cerebrovascular complication during follow-up	24 months later after operation
The incidence of in-stent stenosis after stent deployment	the rate and degree of in-stent stenosis after stent deployment	24 months later after operation

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Collaborators: Beijing Tiantan Hospital; Guangdong Provincial People's Hospital; First Affiliated Hospital of Chongqing Medical University; The Affiliated Hospital Of Southwest Medical University; Guangdong 999 Brain Hospital; Eighth Affiliated Hospital, Sun Yat-sen University; Nanfang Hospital, Southern Medical University
• Investigators: Principal Investigator: Chuanzhi Duan, Ph.D., Department of Neurosurgery, Zhujiang Hospital,Southern Medical University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: December 21, 2017
• First Posted (Actual): January 2, 2018

Study Record Updates

• Last Update Posted (Actual): September 23, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: treatment outcome
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: LC2016ZD024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Anonymized data that support the findings of this article can be provided upon reasonable request by the SESIA steering committee.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No