Clinical trial NCT03387995: Safety and Efficacy of Stent Deployment for Intracranial Aneurysms (SESIA)
Official title: Safety and Efficacy of Stent Deployment for Intracranial Aneurysms: Trials of Clinical Curative Effect, Follow-up Study and Hemodynamics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Treatment Outcome by Stent-assisted Embolization
Keywords: treatment outcome
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
Collaborators: name: Nanfang Hospital, Southern Medical University
name: Guangdong Provincial People's Hospital
name: Beijing Tiantan Hospital
name: First Affiliated Hospital of Chongqing Medical University
name: The Affiliated Hospital Of Southwest Medical University
name: Guangdong 999 Brain Hospital
name: Eighth Affiliated Hospital, Sun Yat-sen University
First posted: 2018-01-02
Enrollment: 4157
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The safety evaluation of interventional therapy
timeFrame: 6 months later after operation
measure: The efficacy evaluation of interventional treatment
timeFrame: 6 months later after operation
measure: Evaluate the relationship between intracranial aneurysm and cyclin dependent
timeFrame: 6 months later after operation
measure: The cerebrovascular complication after interventional therapy
timeFrame: 6 months later after operation
measure: The incidence of in-stent stenosis after stent deployment
timeFrame: 6 months later after operation
Secondary outcomes:
Other outcomes:
measure: The safety evaluation of interventional therapy
timeFrame: 24 months later after operation
measure: The efficacy evaluation of interventional treatment
timeFrame: 24 months later after operation
measure: The cerebrovascular complication after interventional therapy
timeFrame: 24 months later after operation
measure: The incidence of in-stent stenosis after stent deployment
timeFrame: 24 months later after operation
Locations:
city: Guangzhou
country: China
facility: ZhuJiang Hospital,Southern Medical University
state: Guangdong
Study officials:
affiliation: Department of Neurosurgery, Zhujiang Hospital,Southern Medical University
name: Chuanzhi Duan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.