Treatment Outcome by Stent-assisted EmbolizationSESIANCT03387995
Safety and Efficacy of Stent Deployment for Intracranial Aneurysms (SESIA)
An observational study of Treatment Outcome by Stent-assisted Embolization, run by Zhujiang Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Treatment Outcome by Stent-assisted Embolization
- What is being tested?
- LVIS stent, Solitaire stent and Enterprise stent
- Type of treatment
- Medical device
- How many people
- 4,157 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2016to 30 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subject has intracranial aneurysms confirmed by CT arteriography (CTA) or magnetic resonance angiography (MRA) or digital subtraction angiography (DSA).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
ZhuJiang Hospital,Southern Medical University
Guangzhou, Guangdong, 510282
About this study
Official title: 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.
Read the 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.
- Being tested
- LVIS stent, Solitaire stent, Enterprise stent, Neuroform stent, Flow diverter (FD) stent
- Keywords
- treatment outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LVIS stentDevice
The paitents treated by LVIS stent implantation.
Solitaire stentDevice
The paitents treated by Solitaire stent implantation.
Enterprise stentDevice
The paitents treated by Enterprise stent implantation.
Neuroform stentDevice
The paitents treated by Neuroform stent implantation.
Flow diverter (FD) stentDevice
The paitents treated by Enterprise FD implantation.
| Study group | Role | What they receive |
|---|---|---|
| Anterior communicating artery aneurysm | Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent. Receives: Device: LVIS stent; Device: Solitaire stent; Device: Enterprise stent; Device: Neuroform stent; Device: Flow diverter (FD) stent | |
| Middle cerebral artery aneurysm | Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent. Receives: Device: LVIS stent; Device: Solitaire stent; Device: Enterprise stent; Device: Neuroform stent; Device: Flow diverter (FD) stent | |
| Posterior communicating artery aneurysm | Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent. Receives: Device: LVIS stent; Device: Solitaire stent; Device: Enterprise stent; Device: Neuroform stent; Device: Flow diverter (FD) stent | |
| Internal carotid artery aneurysm | Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent. Receives: Device: LVIS stent; Device: Solitaire stent; Device: Enterprise stent; Device: Neuroform stent; Device: Flow diverter (FD) stent | |
| Vertebrobasilar system aneurysms | Contains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent. Receives: Device: LVIS stent; Device: Solitaire stent; Device: Enterprise stent; Device: Neuroform stent; Device: Flow diverter (FD) stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety evaluation of interventional therapy
Modified Rankin Scale (mRS) score to measure the safety of of interventional therapy
Measured: 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
Measured: 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)
Measured: 6 months later after operation
The cerebrovascular complication after interventional therapy
Perioperative and delayed cerebrovascular complication after stent deployment
Measured: 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
Measured: 6 months later after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start1 Sep 2016
- Primary completion30 Dec 2023
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Treatment Outcome by Stent-assisted EmbolizationStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Guangdong Provincial People's Hospital, Beijing Tiantan 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
- Responsible party
- Principal investigator, Duan Chuanzhi, Zhujiang Hospital
- Investigators
- Chuanzhi Duan, Ph.D., Principal investigator, Department of Neurosurgery, Zhujiang Hospital,Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387995
- Sponsor's protocol ID
- LC2016ZD024
- Acronym
- SESIA
- Status last verified
- Sep 2024
- First submitted
- 27 Nov 2017
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymized data that support the findings of this article can be provided upon reasonable request by the SESIA steering committee.
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.
PubMed 21353424Standhardt 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.
PubMed 18258836Ishibashi 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.
PubMed 18845802Gu 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.
PubMed 23201094Ye 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.
PubMed 26170926Li 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.
PubMed 25565057Naggara 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.
PubMed 20634431Mitra 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.
PubMed 17297013Lopes 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.
PubMed 15670395Feng 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.
PubMed 40765506
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Stent Deployment for Intracranial Aneurysms: Trials of Clinical Curative Effect, Follow-up Study and Hemodynamics
- ClinicalTrials.gov ID
- NCT03387995
- Acronym / sponsor ID
- SESIA / LC2016ZD024
- Keywords
- treatment outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,157 participants (actual)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- Nanfang Hospital, Southern Medical University, Guangdong Provincial People's Hospital, Beijing Tiantan 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
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 2 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Anterior communicating artery aneurysm | – | Device: LVIS stent, Device: Solitaire stent, Device: Enterprise stent, Device: Neuroform stent, Device: Flow diverter (FD) stentContains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent. |
| Middle cerebral artery aneurysm | – | Device: LVIS stent, Device: Solitaire stent, Device: Enterprise stent, Device: Neuroform stent, Device: Flow diverter (FD) stentContains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent. |
| Posterior communicating artery aneurysm | – | Device: LVIS stent, Device: Solitaire stent, Device: Enterprise stent, Device: Neuroform stent, Device: Flow diverter (FD) stentContains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent. |
| Internal carotid artery aneurysm | – | Device: LVIS stent, Device: Solitaire stent, Device: Enterprise stent, Device: Neuroform stent, Device: Flow diverter (FD) stentContains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent. |
| Vertebrobasilar system aneurysms | – | Device: LVIS stent, Device: Solitaire stent, Device: Enterprise stent, Device: Neuroform stent, Device: Flow diverter (FD) stentContains 5 subgroups: LVIS stent, Solitire stent, Enterprise stent, Neuroform stent and flow diveter stent. |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subject has intracranial aneurysms confirmed by CT arteriography (CTA) or magnetic resonance angiography (MRA) or digital subtraction angiography (DSA).
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LVIS stentThe paitents treated by LVIS stent implantation. | Device | Anterior communicating artery aneurysm, Internal carotid artery aneurysm, Middle cerebral artery aneurysm, Posterior communicating artery aneurysm, Vertebrobasilar system aneurysms |
| Solitaire stentThe paitents treated by Solitaire stent implantation. | Device | Anterior communicating artery aneurysm, Internal carotid artery aneurysm, Middle cerebral artery aneurysm, Posterior communicating artery aneurysm, Vertebrobasilar system aneurysms |
| Enterprise stentThe paitents treated by Enterprise stent implantation. | Device | Anterior communicating artery aneurysm, Internal carotid artery aneurysm, Middle cerebral artery aneurysm, Posterior communicating artery aneurysm, Vertebrobasilar system aneurysms |
| Neuroform stentThe paitents treated by Neuroform stent implantation. | Device | Anterior communicating artery aneurysm, Internal carotid artery aneurysm, Middle cerebral artery aneurysm, Posterior communicating artery aneurysm, Vertebrobasilar system aneurysms |
| Flow diverter (FD) stentThe paitents treated by Enterprise FD implantation. | Device | Anterior communicating artery aneurysm, Internal carotid artery aneurysm, Middle cerebral artery aneurysm, Posterior communicating artery aneurysm, Vertebrobasilar system aneurysms |
Primary outcome
The safety evaluation of interventional therapy
Time frame: 6 months later after operation
Modified Rankin Scale (mRS) score to measure the safety of of interventional therapy
The efficacy evaluation of interventional treatment
Time frame: 6 months later after operation
Raymond-Ray scale (for common stent) and O'Kelley Morrota scale (for FD) to measure the effectiveness of interventional treatment
Evaluate the relationship between intracranial aneurysm and cyclin dependent
Time frame: 6 months later after operation
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)
The cerebrovascular complication after interventional therapy
Time frame: 6 months later after operation
Perioperative and delayed cerebrovascular complication after stent deployment
The incidence of in-stent stenosis after stent deployment
Time frame: 6 months later after operation
the rate and degree of in-stent stenosis after stent deployment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Background: PubMed 21353424Zhang 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.
- Background: PubMed 18258836Standhardt 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.
- Background: PubMed 18845802Ishibashi 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.
- Background: PubMed 23201094Gu 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.
- Background: PubMed 26170926Ye 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.
- Background: PubMed 25565057Li 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.
- Background: PubMed 20634431Naggara 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.
- Background: PubMed 17297013Mitra 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.
- Background: PubMed 15670395Lopes 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.
- Derived from this study: PubMed 40765506Feng 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.
- Individual participant dataSharing planned: No. Anonymized data that support the findings of this article can be provided upon reasonable request by the SESIA steering committee.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chuanzhi Duan, Ph.D. principal investigator
Department of Neurosurgery, Zhujiang Hospital,Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Treatment Outcome by Stent-assisted Embolization, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety evaluation of interventional therapy (time frame: 6 months later after operation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03387995, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.