Unruptured Intracranial AneurysmFD-SAC BASNCT07754188
Early Complications After Flow Diverter Versus Stent-Assisted Coiling for Unruptured Wide-Neck Intracranial Bifurcation Aneurysms
An observational study of Unruptured Intracranial Aneurysm and Intracranial Bifurcation Aneurysm, run by Nanfang Hospital, Southern Medical University at 3 sites in China.
Trial summary
This prospective real-world cohort study aims to compare early postoperative complications between flow diverter treatment and stent-assisted coiling in patients with unruptured wide-neck intracranial bifurcation aneurysms. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unruptured Intracranial Aneurysm, Intracranial Bifurcation Aneurysm, Wide-Neck Aneurysm
- What is being tested?
- Flow Diverter and Stent-Assisted Coiling
- Type of treatment
- Medical device
- How many people
- 274 participants
- Where
- 3 sitesChina
- Study dates
- 19 Mar 2026to 19 Mar 2028
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18 to 75 years with unruptured, saccular, wide-neck intracranial bifurcation aneurysms diagnosed by CTA, MRA, or DSA who meet the clinical indications for endovascular treatment and are treated at participating centers. Eligible patients must provide written informed consent and will receive either flow diverter treatment or stent-assisted coiling according to the study protocol.
Who may be able to join
- Voluntarily provides written informed consent.
- Aged 18 to 75 years.
- Diagnosed by CTA, MRA, or DSA as having an unruptured, bifurcation, saccular, wide-neck intracranial aneurysm.
- Able to understand the purpose of the study.
Who cannot join
- Patients with two or more multiple aneurysms, all of which require treatment within 1 year.
- Patients with other cerebrovascular diseases such as arteriovenous malformation or moyamoya disease.
- Patients with ruptured aneurysms or narrow-neck aneurysms.
- Patients who experienced stroke, including cerebral hemorrhage or cerebral infarction, within the past 1 month.
- Patients with poor clinical condition, defined as modified Rankin Scale score ≥3.
- Patients who have already planned to undergo surgical or interventional treatment within 3 months.
Show all 15Show fewer
- Patients considered by the investigator to be unsuitable for endovascular treatment, such as those with no suitable vascular access, excessively tortuous vessels, or difficulty in stent delivery.
- Patients unsuitable for anesthesia or endovascular treatment, including those with major heart, lung, liver, spleen, or kidney disease, brain tumor, severe active infection, disseminated intravascular coagulation, or a history of severe psychiatric disorder.
- Patients unable to receive antiplatelet or anticoagulant therapy.
- Patients with a previous or possible severe reaction to contrast agents that would prevent completion of pre-treatment medication or treatment.
- Patients with a known history of allergy to cobalt-chromium or nickel-titanium alloy materials.
- Patients who participated in another drug or medical device clinical trial before enrollment and have not reached the time point of the primary endpoint.
- Pregnant or lactating women.
- Patients with life expectancy less than 12 months.
- Patients judged by the investigator to have poor compliance and inability to complete the study as required
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong
Wenfeng Feng Feng, Principal Investigator, MD, 13501509911, fengwf1967@163.com
- Recruiting
Guangdong Province People's Hospital
Guangzhou
Shengpan Chen, MD, 19801168712@163.com
- Recruiting
Zhujiang Hospital, Southern Medical University
Guangzhou
Xin Feng, Principal Investigator, 11111111@163.com
About this study
Official title: Early Complications After Flow Diverter Versus Stent-Assisted Coiling for Unruptured Wide-Neck Intracranial Bifurcation Aneurysms: A Prospective Real-World Cohort Study
This prospective real-world cohort study aims to compare early postoperative complications between flow diverter treatment and stent-assisted coiling in patients with unruptured wide-neck intracranial bifurcation aneurysms. A total of 274 patients from three centers in China will be enrolled and assigned to the flow diverter group or the stent-assisted coiling group according to the treatment received in routine clinical practice. The primary outcome is a composite of any stroke or all-cause death within 30 days after the procedure. The study will also collect demographic, clinical, laboratory, imaging, aneurysm morphological, procedural, and follow-up data to evaluate the safety of these two endovascular treatment strategies in a real-world setting.
Read the detailed description
Intracranial bifurcation aneurysms are common and are challenging to treat because of their complex anatomy. Flow diverters have emerged as an innovative endovascular therapy and have shown preliminary efficacy in bifurcation aneurysms. However, compared with conventional stent-assisted coiling, real-world evidence regarding early postoperative complication risks and related influencing factors remains limited.
This study will establish a prospective multicenter real-world database to compare the incidence of early complications after treatment with a flow diverter versus stent-assisted coiling in patients with unruptured wide-neck intracranial bifurcation aneurysms. Eligible patients who provide informed consent and meet the inclusion and exclusion criteria will be enrolled from three centers in China. Patients treated with a flow diverter will enter the flow diverter group, and patients treated with stent-assisted coiling will enter the stent-assisted coiling group.
All patients will undergo preoperative evaluation, perioperative management, postoperative antiplatelet therapy, and follow-up according to clinical practice and relevant guidelines. Data collected will include demographic characteristics, medical history, physical examination, laboratory tests, imaging findings, aneurysm morphology, procedural details, device information, medication history, and adverse events. Follow-up will be performed at 30 days after treatment to assess safety outcomes.
- Being tested
- Flow Diverter, Stent-Assisted Coiling
- Keywords
- Intracranial bifurcation aneurysm, Wide-neck aneurysm, Flow diverter, Stent-assisted coiling, Endovascular treatment, Early complications, Stroke, All-cause mortality, Real-world study, Prospective cohort
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow DiverterDevice
Flow diverter treatment will be performed according to routine clinical practice and relevant guidelines. A flow-diverting stent will be deployed to cover the aneurysm neck after angiographic evaluation and device sizing. Perioperative management and antiplatelet therapy will be performed according to the study protocol and clinical practice.
Stent-Assisted CoilingDevice
Stent-assisted coiling will be performed according to routine clinical practice and relevant guidelines. A stent will be deployed across the aneurysm neck, followed by coil embolization of the aneurysm. Perioperative management and antiplatelet therapy will be performed according to the study protocol and clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Flow Diverter Group | Patients with unruptured wide-neck intracranial bifurcation aneurysms who receive flow diverter treatment in routine clinical practice. Receives: Device: Flow Diverter | |
| Stent-Assisted Coiling Group | Patients with unruptured wide-neck intracranial bifurcation aneurysms who receive stent-assisted coiling in routine clinical practice. Receives: Device: Stent-Assisted Coiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite incidence of any stroke or all-cause death within 30 days after procedure
The primary outcome is the occurrence of any stroke or all-cause death within 30 days after the endovascular procedure. Stroke is defined as an acute onset of focal or global neurological dysfunction caused by vascular injury of the brain, spinal cord, or retina due to hemorrhage or infarction, with symptoms lasting 24 hours or longer.
Measured: Within 30 days after procedure
Secondary outcomes (4)
Incidence of any stroke within 30 days after procedure
Incidence of any ischemic or hemorrhagic stroke within 30 days after the procedure.
Measured: Within 30 days after procedure
Incidence of transient ischemic attack within 30 days after procedure
Incidence of transient ischemic attack within 30 days after the procedure. Transient ischemic attack is defined as a transient episode of focal neurological dysfunction caused by ischemia of the brain, spinal cord, or retina, with symptoms lasting less than 24 hours and without acute infarction.
Measured: Within 30 days after procedure
Incidence of all-cause death within 30 days after procedure
Incidence of death from any cause within 30 days after the procedure.
Measured: Within 30 days after procedure
Incidence of adverse events and serious adverse events within 30 days after procedure
Incidence of adverse events and serious adverse events recorded during the perioperative period and follow-up period.
Measured: Within 30 days after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start19 Mar 2026
- Primary completion19 Mar 2027 (estimated)
- Study completion19 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Unruptured Intracranial AneurysmStudies of the same condition, open and under way.
- 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
- 274 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhujiang Hospital, Guangdong Province People's Hospital
- Responsible party
- Principal investigator, Feng wen feng, Nanfang Hospital, Southern Medical University
- Investigators
- Wenfeng Feng, MD, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754188
- Sponsor's protocol ID
- 2026STI341
- Other IDs
- 2026STI341
- Acronym
- FD-SAC BAS
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The individual participant data sharing plan has not yet been determined and will be decided according to institutional policy, ethics committee requirements, and participant privacy considerations.
Publications
Rouchaud A, Brinjikji W, Lanzino G, Cloft HJ, Kadirvel R, Kallmes DF. Delayed hemorrhagic complications after flow diversion for intracranial aneurysms: a literature overview. Neuroradiology. 2016 Feb;58(2):171-7. doi: 10.1007/s00234-015-1615-4. Epub 2015 Nov 9.
PubMed 26553302Cagnazzo F, Fanti A, Lefevre PH, Derraz I, Dargazanli C, Gascou G, Riquelme C, Ahmed R, Bonafe A, Costalat V. Distal anterior cerebral artery aneurysms treated with flow diversion: experience of a large-volume center and systematic review of the literature. J Neurointerv Surg. 2021 Jan;13(1):42-48. doi: 10.1136/neurintsurg-2020-015980. Epub 2020 May 26.
PubMed 32457222Choi JH, Park JE, Kim MJ, Kim BS, Shin YS. Aneurysmal Neck Clipping as the Primary Treatment Option for Both Ruptured and Unruptured Middle Cerebral Artery Aneurysms. J Korean Neurosurg Soc. 2016 May;59(3):269-75. doi: 10.3340/jkns.2016.59.3.269. Epub 2016 May 10.
PubMed 27226859Cagnazzo F, Limbucci N, Nappini S, Renieri L, Rosi A, Laiso A, Tiziano di Carlo D, Perrini P, Mangiafico S. Y-Stent-Assisted Coiling of Wide-Neck Bifurcation Intracranial Aneurysms: A Meta-Analysis. AJNR Am J Neuroradiol. 2019 Jan;40(1):122-128. doi: 10.3174/ajnr.A5900. Epub 2018 Dec 6.
PubMed 30523146Kashkoush A, El-Abtah ME, Petitt JC, Glauser G, Winkelman R, Achey RL, Davison M, Abdulrazzak MA, Hussain SM, Toth G, Bain M, Moore N. Flow diversion for the treatment of intracranial bifurcation aneurysms: a systematic review and meta-analysis. J Neurointerv Surg. 2024 Aug 14;16(9):921-927. doi: 10.1136/jnis-2023-020582.
PubMed 37541838Brinjikji W, Murad MH, Lanzino G, Cloft HJ, Kallmes DF. Endovascular treatment of intracranial aneurysms with flow diverters: a meta-analysis. Stroke. 2013 Feb;44(2):442-7. doi: 10.1161/STROKEAHA.112.678151. Epub 2013 Jan 15.
PubMed 23321438Kang H, Luo B, Liu J, Zhang H, Li T, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Zhang Y, Yang X. Postoperative occlusion degree after flow-diverter placement with adjunctive coiling: analysis of complications. J Neurointerv Surg. 2022 Apr;14(4):371-375. doi: 10.1136/neurintsurg-2021-017445. Epub 2021 May 13.
PubMed 33986109Cekirge HS, Saatci I. A New Aneurysm Occlusion Classification after the Impact of Flow Modification. AJNR Am J Neuroradiol. 2016 Jan;37(1):19-24. doi: 10.3174/ajnr.A4489. Epub 2015 Aug 27.
PubMed 26316566Byoun HS, Lim JW, Han MH, Jeong EO, Koh HS, Kwon HJ. Coil embolization of the middle cerebral artery bifurcation aneurysms: Feasibility and durability. J Clin Neurosci. 2024 Aug;126:294-306. doi: 10.1016/j.jocn.2024.06.016. Epub 2024 Jul 13.
PubMed 39002303Saleme S, Iosif C, Ponomarjova S, Mendes G, Camilleri Y, Caire F, Boncoeur MP, Mounayer C. Flow-diverting stents for intracranial bifurcation aneurysm treatment. Neurosurgery. 2014 Dec;75(6):623-31; quiz 631. doi: 10.1227/NEU.0000000000000522.
PubMed 25121791Salem MM, Khorasanizadeh M, Lay SV, Renieri L, Kuhn AL, Sweid A, Massari F, Moore JM, Tjoumakaris SI, Jabbour P, Puri AS, Ogilvy CS, Jankowitz BT, Burkhardt JK, Kan P, Limbucci N, Cognard C, Thomas AJ. Endoluminal flow diverting stents for middle cerebral artery bifurcation aneurysms: multicenter cohort. J Neurointerv Surg. 2022 Nov;14(11):1084-1089. doi: 10.1136/neurintsurg-2021-018224. Epub 2021 Nov 3.
PubMed 34732531Iosif C, Mounayer C, Yavuz K, Saleme S, Geyik S, Cekirge HS, Saatci I. Middle Cerebral Artery Bifurcation Aneurysms Treated by Extrasaccular Flow Diverters: Midterm Angiographic Evolution and Clinical Outcome. AJNR Am J Neuroradiol. 2017 Feb;38(2):310-316. doi: 10.3174/ajnr.A5022. Epub 2016 Dec 15.
PubMed 27979794Limbucci N, Leone G, Renieri L, Nappini S, Cagnazzo F, Laiso A, Muto M, Mangiafico S. Expanding Indications for Flow Diverters: Distal Aneurysms, Bifurcation Aneurysms, Small Aneurysms, Previously Coiled Aneurysms and Clipped Aneurysms, and Carotid Cavernous Fistulas. Neurosurgery. 2020 Jan 1;86(Suppl 1):S85-S94. doi: 10.1093/neuros/nyz334.
PubMed 31838532Turhon M, Kang H, Li M, Liu J, Zhang Y, Zhang Y, Huang J, Luo B, Liu J, Zhang H, Li T, Song D, Zhao Y, Guan S, Aximujiang A, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Zhang X, Gu Y, Yang X. Treatment of fusiform aneurysms with a pipeline embolization device: a multicenter cohort study. J Neurointerv Surg. 2023 Apr;15(4):315-320. doi: 10.1136/neurintsurg-2021-018539. Epub 2022 Mar 30.
PubMed 35354575Luo B, Kang H, Zhang H, Li T, Liu J, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X. Pipeline Embolization device for intracranial aneurysms in a large Chinese cohort: factors related to aneurysm occlusion. Ther Adv Neurol Disord. 2020 Nov 2;13:1756286420967828. doi: 10.1177/1756286420967828. eCollection 2020.
PubMed 33224273
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Complications After Flow Diverter Versus Stent-Assisted Coiling for Unruptured Wide-Neck Intracranial Bifurcation Aneurysms: A Prospective Real-World Cohort Study
- ClinicalTrials.gov ID
- NCT07754188
- Acronym / sponsor ID
- FD-SAC BAS / 2026STI341
- Keywords
- Intracranial bifurcation aneurysm, Wide-neck aneurysm, Flow diverter, Stent-assisted coiling, Endovascular treatment, Early complications, Stroke, All-cause mortality
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Zhujiang Hospital, Guangdong Province People's Hospital
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 19 Mar 2027 (estimated)
- Study completion
- 19 Mar 2028 (estimated)
- First posted
- 10 Aug 2026 (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.
This prospective real-world cohort study aims to compare early postoperative complications between flow diverter treatment and stent-assisted coiling in patients with unruptured wide-neck intracranial bifurcation aneurysms. A total of 274 patients from three centers in China will be enrolled and assigned to the flow diverter group or the stent-assisted coiling group according to the treatment received in routine clinical practice. The primary outcome is a composite of any stroke or all-cause death within 30 days after the procedure. The study will also collect demographic, clinical, laboratory, imaging, aneurysm morphological, procedural, and follow-up data to evaluate the safety of these two endovascular treatment strategies in a real-world setting.
Detailed description
Intracranial bifurcation aneurysms are common and are challenging to treat because of their complex anatomy. Flow diverters have emerged as an innovative endovascular therapy and have shown preliminary efficacy in bifurcation aneurysms. However, compared with conventional stent-assisted coiling, real-world evidence regarding early postoperative complication risks and related influencing factors remains limited.
This study will establish a prospective multicenter real-world database to compare the incidence of early complications after treatment with a flow diverter versus stent-assisted coiling in patients with unruptured wide-neck intracranial bifurcation aneurysms. Eligible patients who provide informed consent and meet the inclusion and exclusion criteria will be enrolled from three centers in China. Patients treated with a flow diverter will enter the flow diverter group, and patients treated with stent-assisted coiling will enter the stent-assisted coiling group.
All patients will undergo preoperative evaluation, perioperative management, postoperative antiplatelet therapy, and follow-up according to clinical practice and relevant guidelines. Data collected will include demographic characteristics, medical history, physical examination, laboratory tests, imaging findings, aneurysm morphology, procedural details, device information, medication history, and adverse events. Follow-up will be performed at 30 days after treatment to assess safety outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flow Diverter Group | – | Device: Flow DiverterPatients with unruptured wide-neck intracranial bifurcation aneurysms who receive flow diverter treatment in routine clinical practice. |
| Stent-Assisted Coiling Group | – | Device: Stent-Assisted CoilingPatients with unruptured wide-neck intracranial bifurcation aneurysms who receive stent-assisted coiling in routine clinical practice. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 to 75 years with unruptured, saccular, wide-neck intracranial bifurcation aneurysms diagnosed by CTA, MRA, or DSA who meet the clinical indications for endovascular treatment and are treated at participating centers. Eligible patients must provide written informed consent and will receive either flow diverter treatment or stent-assisted coiling according to the study protocol.
Key inclusion criteria (4 listed)
- Voluntarily provides written informed consent.
- Aged 18 to 75 years.
- Diagnosed by CTA, MRA, or DSA as having an unruptured, bifurcation, saccular, wide-neck intracranial aneurysm.
- Able to understand the purpose of the study.
Key exclusion criteria (15 listed)
- Patients with two or more multiple aneurysms, all of which require treatment within 1 year.
- Patients with other cerebrovascular diseases such as arteriovenous malformation or moyamoya disease.
- Patients with ruptured aneurysms or narrow-neck aneurysms.
- Patients who experienced stroke, including cerebral hemorrhage or cerebral infarction, within the past 1 month.
- Patients with poor clinical condition, defined as modified Rankin Scale score ≥3.
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 |
|---|---|---|
| Flow DiverterFlow diverter treatment will be performed according to routine clinical practice and relevant guidelines. A flow-diverting stent will be deployed to cover the aneurysm neck after angiographic evaluation and device sizing. Perioperative management and antiplatelet therapy will be performed according to the study protocol and clinical practice. | Device | Flow Diverter Group |
| Stent-Assisted CoilingStent-assisted coiling will be performed according to routine clinical practice and relevant guidelines. A stent will be deployed across the aneurysm neck, followed by coil embolization of the aneurysm. Perioperative management and antiplatelet therapy will be performed according to the study protocol and clinical practice. | Device | Stent-Assisted Coiling Group |
Primary outcome
Composite incidence of any stroke or all-cause death within 30 days after procedure
Time frame: Within 30 days after procedure
The primary outcome is the occurrence of any stroke or all-cause death within 30 days after the endovascular procedure. Stroke is defined as an acute onset of focal or global neurological dysfunction caused by vascular injury of the brain, spinal cord, or retina due to hemorrhage or infarction, with symptoms lasting 24 hours or longer.
4 secondary outcomes
Incidence of any stroke within 30 days after procedure
Time frame: Within 30 days after procedure
Incidence of transient ischemic attack within 30 days after procedure
Time frame: Within 30 days after procedure
Incidence of all-cause death within 30 days after procedure
Time frame: Within 30 days after procedure
Incidence of adverse events and serious adverse events within 30 days after procedure
Time frame: Within 30 days after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Results publication: PubMed 26553302Rouchaud A, Brinjikji W, Lanzino G, Cloft HJ, Kadirvel R, Kallmes DF. Delayed hemorrhagic complications after flow diversion for intracranial aneurysms: a literature overview. Neuroradiology. 2016 Feb;58(2):171-7. doi: 10.1007/s00234-015-1615-4. Epub 2015 Nov 9.
- Results publication: PubMed 32457222Cagnazzo F, Fanti A, Lefevre PH, Derraz I, Dargazanli C, Gascou G, Riquelme C, Ahmed R, Bonafe A, Costalat V. Distal anterior cerebral artery aneurysms treated with flow diversion: experience of a large-volume center and systematic review of the literature. J Neurointerv Surg. 2021 Jan;13(1):42-48. doi: 10.1136/neurintsurg-2020-015980. Epub 2020 May 26.
- Results publication: PubMed 27226859Choi JH, Park JE, Kim MJ, Kim BS, Shin YS. Aneurysmal Neck Clipping as the Primary Treatment Option for Both Ruptured and Unruptured Middle Cerebral Artery Aneurysms. J Korean Neurosurg Soc. 2016 May;59(3):269-75. doi: 10.3340/jkns.2016.59.3.269. Epub 2016 May 10.
- Results publication: PubMed 30523146Cagnazzo F, Limbucci N, Nappini S, Renieri L, Rosi A, Laiso A, Tiziano di Carlo D, Perrini P, Mangiafico S. Y-Stent-Assisted Coiling of Wide-Neck Bifurcation Intracranial Aneurysms: A Meta-Analysis. AJNR Am J Neuroradiol. 2019 Jan;40(1):122-128. doi: 10.3174/ajnr.A5900. Epub 2018 Dec 6.
- Results publication: PubMed 37541838Kashkoush A, El-Abtah ME, Petitt JC, Glauser G, Winkelman R, Achey RL, Davison M, Abdulrazzak MA, Hussain SM, Toth G, Bain M, Moore N. Flow diversion for the treatment of intracranial bifurcation aneurysms: a systematic review and meta-analysis. J Neurointerv Surg. 2024 Aug 14;16(9):921-927. doi: 10.1136/jnis-2023-020582.
- Results publication: PubMed 23321438Brinjikji W, Murad MH, Lanzino G, Cloft HJ, Kallmes DF. Endovascular treatment of intracranial aneurysms with flow diverters: a meta-analysis. Stroke. 2013 Feb;44(2):442-7. doi: 10.1161/STROKEAHA.112.678151. Epub 2013 Jan 15.
- Results publication: PubMed 33986109Kang H, Luo B, Liu J, Zhang H, Li T, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Zhang Y, Yang X. Postoperative occlusion degree after flow-diverter placement with adjunctive coiling: analysis of complications. J Neurointerv Surg. 2022 Apr;14(4):371-375. doi: 10.1136/neurintsurg-2021-017445. Epub 2021 May 13.
- Results publication: PubMed 26316566Cekirge HS, Saatci I. A New Aneurysm Occlusion Classification after the Impact of Flow Modification. AJNR Am J Neuroradiol. 2016 Jan;37(1):19-24. doi: 10.3174/ajnr.A4489. Epub 2015 Aug 27.
- Results publication: PubMed 39002303Byoun HS, Lim JW, Han MH, Jeong EO, Koh HS, Kwon HJ. Coil embolization of the middle cerebral artery bifurcation aneurysms: Feasibility and durability. J Clin Neurosci. 2024 Aug;126:294-306. doi: 10.1016/j.jocn.2024.06.016. Epub 2024 Jul 13.
- Results publication: PubMed 25121791Saleme S, Iosif C, Ponomarjova S, Mendes G, Camilleri Y, Caire F, Boncoeur MP, Mounayer C. Flow-diverting stents for intracranial bifurcation aneurysm treatment. Neurosurgery. 2014 Dec;75(6):623-31; quiz 631. doi: 10.1227/NEU.0000000000000522.
- Results publication: PubMed 34732531Salem MM, Khorasanizadeh M, Lay SV, Renieri L, Kuhn AL, Sweid A, Massari F, Moore JM, Tjoumakaris SI, Jabbour P, Puri AS, Ogilvy CS, Jankowitz BT, Burkhardt JK, Kan P, Limbucci N, Cognard C, Thomas AJ. Endoluminal flow diverting stents for middle cerebral artery bifurcation aneurysms: multicenter cohort. J Neurointerv Surg. 2022 Nov;14(11):1084-1089. doi: 10.1136/neurintsurg-2021-018224. Epub 2021 Nov 3.
- Results publication: PubMed 27979794Iosif C, Mounayer C, Yavuz K, Saleme S, Geyik S, Cekirge HS, Saatci I. Middle Cerebral Artery Bifurcation Aneurysms Treated by Extrasaccular Flow Diverters: Midterm Angiographic Evolution and Clinical Outcome. AJNR Am J Neuroradiol. 2017 Feb;38(2):310-316. doi: 10.3174/ajnr.A5022. Epub 2016 Dec 15.
- Individual participant dataSharing planned: Undecided. The individual participant data sharing plan has not yet been determined and will be decided according to institutional policy, ethics committee requirements, and participant privacy considerations.
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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.
Wenfeng Feng, MD principal investigator
Nanfang Hospital, Southern Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unruptured Intracranial Aneurysm and Intracranial Bifurcation Aneurysm, run by Nanfang Hospital, Southern Medical University at 3 sites 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 4 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huibin Kang Study Contact, MD (13520296286, kanghuibindoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite incidence of any stroke or all-cause death within 30 days after procedure (time frame: Within 30 days after procedure). 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 NCT07754188, which also lists 30 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 10 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.