Unruptured Intracranial Wide-neck Bifurcation AneurysmsFD-BWANCT07707076
Flow Diverter Versus Conventional Endovascular Treatment for Unruptured Wide-Neck Bifurcation Aneurysms (FD-BWA Trial)
A study testing Flow Diverter Group and Stent Assisted Coiling Group in people with Unruptured Intracranial Wide-neck Bifurcation Aneurysms, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Brief Summary： The goal of this clinical trial is to compare whether the traditional approach (stent-assisted coiling) is associated with a lower complication rate than flow diverter (Pipeline™) treatment for unruptured intracranial wide-neck bifurcation aneurysms. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Unruptured Intracranial Wide-neck Bifurcation Aneurysms
- What is being tested?
- Flow Diverter Group and Stent Assisted Coiling Group
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2026to 30 Jun 2030
- Phase
- Interventional
- 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
Who may be able to join
- Age 18-75 years;
- Diagnosis of unruptured intracranial, bifurcation, saccular, wide-neck aneurysm by DSA/CTA/MRA;
- Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form.
Who cannot join
- Patients with two or more multiple aneurysms that all require treatment within 1 year;
- Concomitant cerebrovascular diseases such as arteriovenous malformation, moyamoya disease;
- Ruptured aneurysms and narrow-neck aneurysms;
- Patients who have had a stroke (cerebral hemorrhage, cerebral infarction) within the past 1 month;
- Extremely poor clinical condition, modified Rankin Score ≥3;
- Patients already scheduled for surgery/interventional procedure within 3 months;
Show all 15Show fewer
- Patients deemed unsuitable for interventional treatment by the investigator (e.g., no suitable vascular access, excessively tortuous vessels, difficulty delivering stent);
- Patients unsuitable for anesthesia or endovascular surgery, such as major diseases of heart, lung, liver, spleen, kidney, brain tumors, severe active infections, disseminated intravascular coagulation, severe mental illness;
- Patients unable to receive antiplatelet or anticoagulant therapy;
- Patients who have had or may have severe reactions to contrast media precluding pre-treatment medication;
- Patients with a definite history of allergy to cobalt-chromium, nickel-titanium alloy materials;
- Participation in other drug or medical device clinical trials before enrollment without reaching the primary endpoint timeframe;
- Pregnant or breastfeeding women;
- Patient's life expectancy less than 12 months;
- Investigator judges that the patient has poor compliance and cannot complete the study as required.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Huibin Kang, MD, 13520296286, kanghuibindoctor@163.com
Wenfeng Feng, MD, +8602062787665, fengwf1967@163.com
About this study
Official title: Traditional Approach Versus Flow Diverter for Unruptured Intracranial Wide-neck Bifurcation Aneurysms: a Prospective International Multicenter Randomized Controlled Study (FD-BWA Study)
Brief Summary：
The goal of this clinical trial is to compare whether the traditional approach (stent-assisted coiling) is associated with a lower complication rate than flow diverter (Pipeline™) treatment for unruptured intracranial wide-neck bifurcation aneurysms. It will also evaluate the long-term imaging outcomes and safety of both treatments. The main questions it aims to answer are:
Read more
- Does the traditional approach result in a lower rate of any stroke or all-cause death within one year after treatment compared to the flow diverter?
- What medical problems do participants experience during and after each treatment?
- What are the imaging cure and stability rates at 1, 2, and 5 years after treatment?
Researchers will compare the traditional approach (stent-assisted coiling) with the flow diverter (Pipeline™) to determine which treatment has better safety and efficacy outcomes.
Participants will:
- Be randomly assigned to receive either the flow diverter or traditional stent-assisted coiling
- Undergo the assigned endovascular procedure
- Return for follow-up visits at 30 days, 6 months, 1 year, 2 years, and 5 years after surgery for clinical assessments and imaging examinations (DSA, MRA, or CTA)
- Being tested
- Flow Diverter Group, Stent Assisted Coiling Group
- Keywords
- intracranial aneurysms, wide-neck, bifurcation, flow diverter, unruptured
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow Diverter GroupDevice
Flow diversion with the Pipeline™ (Flex/Shield) device for the treatment of unruptured intracranial bifurcation wide-necked aneurysms in the experimental group.
Stent Assisted Coiling GroupDevice
Stent-assisted coiling for the treatment of unruptured intracranial bifurcation wide-necked aneurysms in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Stent Assisted Coiling Group | Active comparator | Traditional Group (Stent Assisted Coiling):
The patient is placed in a supine position. After satisfactory general anesthesia, the right groin area is routinely disinfected and draped. The right femoral artery sheath is replaced with an 8F sheath. Systemic heparinization is administered, followed by continuous pressurized infusion. A 6F long sheath plus a 5F multifunction catheter are advanced with a Terumo guidewire, and the long sheath is positioned in the left vertebral artery. A micro guidewire is used with a microcatheter to selectively catheterize the left posterior cerebral artery P2 segment, and then the microcatheter is advanced into the aneurysm. Through the microcatheter, one coil is semi deployed to form a framing coil, then one stent is deployed through the stent catheter to cover the aneurysm neck. After the first framing coil is detached, several additional coils are sequentially deployed to embolize the aneurysm. Follow up angiography shows no opacification of the a Receives: Device: Stent Assisted Coiling Group |
| Flow Diverter Group | Experimental | Flow Diverter Group:
The patient is placed in a supine position. The right groin area is routinely disinfected and draped. Local infiltration anesthesia is applied at the puncture site, and the right femoral artery is punctured using the Seldinger technique. An 8F sheath is inserted, systemic heparinization is administered, and continuous pressurized infusion is started. A 6F long sheath is advanced to the origin of the right internal carotid artery with the assistance of a Terumo guidewire and a multifunction catheter. A 5F intermediate catheter is advanced inside the long sheath to the petrous segment of the right internal carotid artery. 3D cerebral angiography is performed, and after a suitable working angle is obtained, a stent catheter is advanced to the right middle cerebral artery M3 segment with micro guidewire assistance. Manual injection shows no hemorrhage, confirming the true lumen. After calibration and measurement, one flow diverter stent is deployed to cover the ane Receives: Device: Flow Diverter Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complications at 1 year postoperatively in patients treated with different modalities.
Any stroke, all-cause death events within 1 year post-surgery.
Definitions:
- Stroke defined as: acute focal or global neurological dysfunction due to vascular injury of brain, spinal cord or retina caused by hemorrhage or infarction, symptom duration ≥24 hours, including symptomatic branch stenosis/occlusion due to branch coverage;
- TIA: transient focal neurological dysfunction due to brain, spinal cord or retinal ischemia, symptom duration <24 hours, without acute infarction;
Measured: 1 year
Secondary outcomes (1)
Aneurysm occlusion rate and stability rate after different treatment modalities.
Imaging cure rate （Raymond-Roy grade I) at 1, 2, and 5 years post-surgery.
Definitions:
Raymond-Roy grade: Class I: complete occlusion, no contrast filling in sac or neck; Class II: neck remnant, sac obliterated, contrast in neck; Class III: aneurysm remnant, contrast in sac.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start10 Feb 2026
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Unruptured Intracranial Wide-neck Bifurcation AneurysmsStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Second People's Hospital, Guangdong Provincial People's Hospital, Liv Hospital Ankara, ZhuHai Hospital, West China Hospital, Beijing Tiantan Hospital, Henan Provincial People's Hospital, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China, Guangdong Second Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, Xuanwu Hospital, Beijing, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707076
- Sponsor's protocol ID
- NFEC-2025-738
- Acronym
- FD-BWA
- Status last verified
- Jul 2026
- First submitted
- 29 Mar 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: clinical and imaging data
Publications
Choi 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 27226859Brinjikji 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 23321438Cekirge 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 31838532Luo 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 33224273Kang H, Zhou Y, Luo B, Lv N, Zhang H, Li T, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X, Liu J. Pipeline Embolization Device for Intracranial Aneurysms in a Large Chinese Cohort: Complication Risk Factor Analysis. Neurotherapeutics. 2021 Apr;18(2):1198-1206. doi: 10.1007/s13311-020-00990-8. Epub 2021 Jan 14.
PubMed 33447904O'Kelly CJ, Spears J, Chow M, Wong J, Boulton M, Weill A, Willinsky RA, Kelly M, Marotta TR. Canadian experience with the pipeline embolization device for repair of unruptured intracranial aneurysms. AJNR Am J Neuroradiol. 2013 Feb;34(2):381-7. doi: 10.3174/ajnr.A3224. Epub 2012 Aug 2.
PubMed 22859284Becske T, Potts MB, Shapiro M, Kallmes DF, Brinjikji W, Saatci I, McDougall CG, Szikora I, Lanzino G, Moran CJ, Woo HH, Lopes DK, Berez AL, Cher DJ, Siddiqui AH, Levy EI, Albuquerque FC, Fiorella DJ, Berentei Z, Marosfoi M, Cekirge SH, Nelson PK. Pipeline for uncoilable or failed aneurysms: 3-year follow-up results. J Neurosurg. 2017 Jul;127(1):81-88. doi: 10.3171/2015.6.JNS15311. Epub 2016 Oct 14.
PubMed 27739944Becske T, Kallmes DF, Saatci I, McDougall CG, Szikora I, Lanzino G, Moran CJ, Woo HH, Lopes DK, Berez AL, Cher DJ, Siddiqui AH, Levy EI, Albuquerque FC, Fiorella DJ, Berentei Z, Marosfoi M, Cekirge SH, Nelson PK. Pipeline for uncoilable or failed aneurysms: results from a multicenter clinical trial. Radiology. 2013 Jun;267(3):858-68. doi: 10.1148/radiol.13120099. Epub 2013 Feb 15.
PubMed 23418004Jiang Chunyu, Wang Jianbo: Application of flow diverter in interventional treatment of intracranial aneurysms. Journal of Interventional Radiology 2014, 23(3):267-271
Kallmes DF, Ding YH, Dai D, Kadirvel R, Lewis DA, Cloft HJ. A new endoluminal, flow-disrupting device for treatment of saccular aneurysms. Stroke. 2007 Aug;38(8):2346-52. doi: 10.1161/STROKEAHA.106.479576. Epub 2007 Jul 5.
PubMed 17615366
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Approach Versus Flow Diverter for Unruptured Intracranial Wide-neck Bifurcation Aneurysms: a Prospective International Multicenter Randomized Controlled Study (FD-BWA Study)
- ClinicalTrials.gov ID
- NCT07707076
- Acronym / sponsor ID
- FD-BWA / NFEC-2025-738
- Keywords
- intracranial aneurysms, wide-neck, bifurcation, flow diverter, unruptured
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Shenzhen Second People's Hospital, Guangdong Provincial People's Hospital, Liv Hospital Ankara, ZhuHai Hospital, West China Hospital, Beijing Tiantan Hospital, Henan Provincial People's Hospital, Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China, Guangdong Second Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University, Xuanwu Hospital, Beijing, Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 16 Jul 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.
Brief Summary：
The goal of this clinical trial is to compare whether the traditional approach (stent-assisted coiling) is associated with a lower complication rate than flow diverter (Pipeline™) treatment for unruptured intracranial wide-neck bifurcation aneurysms. It will also evaluate the long-term imaging outcomes and safety of both treatments. The main questions it aims to answer are:
- Does the traditional approach result in a lower rate of any stroke or all-cause death within one year after treatment compared to the flow diverter?
- What medical problems do participants experience during and after each treatment?
- What are the imaging cure and stability rates at 1, 2, and 5 years after treatment?
Researchers will compare the traditional approach (stent-assisted coiling) with the flow diverter (Pipeline™) to determine which treatment has better safety and efficacy outcomes.
Participants will:
- Be randomly assigned to receive either the flow diverter or traditional stent-assisted coiling
- Undergo the assigned endovascular procedure
- Return for follow-up visits at 30 days, 6 months, 1 year, 2 years, and 5 years after surgery for clinical assessments and imaging examinations (DSA, MRA, or CTA)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stent Assisted Coiling Group | Active comparator | Device: Stent Assisted Coiling GroupTraditional Group (Stent Assisted Coiling): The patient is placed in a supine position. After satisfactory general anesthesia, the right groin area is routinely disinfected and draped. The right femoral artery sheath is replaced with an 8F sheath. Systemic heparinization is administered, followed by continuous pressurized infusion. A 6F long sheath plus a 5F multifunction catheter are advanced with a Terumo guidewire, and the long sheath is positioned in the left vertebral artery. A micro guidewire is used with a microcatheter to selectively catheterize the left posterior cerebral artery P2 segment, and then the microcatheter is advanced into the aneurysm. Through the microcatheter, one coil is semi deployed to form a framing coil, then one stent is deployed through the stent catheter to cover the aneurysm neck. After the first framing coil is detached, several additional coils are sequentially deployed to embolize the aneurysm. Follow up angiography shows no opacification of the a |
| Flow Diverter Group | Experimental | Device: Flow Diverter GroupFlow Diverter Group: The patient is placed in a supine position. The right groin area is routinely disinfected and draped. Local infiltration anesthesia is applied at the puncture site, and the right femoral artery is punctured using the Seldinger technique. An 8F sheath is inserted, systemic heparinization is administered, and continuous pressurized infusion is started. A 6F long sheath is advanced to the origin of the right internal carotid artery with the assistance of a Terumo guidewire and a multifunction catheter. A 5F intermediate catheter is advanced inside the long sheath to the petrous segment of the right internal carotid artery. 3D cerebral angiography is performed, and after a suitable working angle is obtained, a stent catheter is advanced to the right middle cerebral artery M3 segment with micro guidewire assistance. Manual injection shows no hemorrhage, confirming the true lumen. After calibration and measurement, one flow diverter stent is deployed to cover the ane |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-75 years;
- Diagnosis of unruptured intracranial, bifurcation, saccular, wide-neck aneurysm by DSA/CTA/MRA;
- Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form.
Key exclusion criteria (15 listed)
- Patients with two or more multiple aneurysms that all require treatment within 1 year;
- Concomitant cerebrovascular diseases such as arteriovenous malformation, moyamoya disease;
- Ruptured aneurysms and narrow-neck aneurysms;
- Patients who have had a stroke (cerebral hemorrhage, cerebral infarction) within the past 1 month;
- Extremely poor clinical condition, modified Rankin 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 Diverter GroupFlow diversion with the Pipeline™ (Flex/Shield) device for the treatment of unruptured intracranial bifurcation wide-necked aneurysms in the experimental group. | Device | Flow Diverter Group |
| Stent Assisted Coiling GroupStent-assisted coiling for the treatment of unruptured intracranial bifurcation wide-necked aneurysms in the control group. | Device | Stent Assisted Coiling Group |
Primary outcome
Incidence of complications at 1 year postoperatively in patients treated with different modalities.
Time frame: 1 year
Any stroke, all-cause death events within 1 year post-surgery. Definitions: 1. Stroke defined as: acute focal or global neurological dysfunction due to vascular injury of brain, spinal cord or retina caused by hemorrhage or infarction, symptom duration ≥24 hours, including symptomatic branch stenosis/occlusion due to branch coverage; 2. TIA: transient focal neurological dysfunction due to brain, spinal cord or retinal ischemia, symptom duration <24 hours, without acute infarction;
1 secondary outcome
Aneurysm occlusion rate and stability rate after different treatment modalities.
Time frame: 5 years
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 16 Jul 2026.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: 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.
- Background: PubMed 31838532Limbucci 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.
- Background: PubMed 33224273Luo 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.
- Background: PubMed 33447904Kang H, Zhou Y, Luo B, Lv N, Zhang H, Li T, Song D, Zhao Y, Guan S, Maimaitili A, Wang Y, Feng W, Wang Y, Wan J, Mao G, Shi H, Yang X, Liu J. Pipeline Embolization Device for Intracranial Aneurysms in a Large Chinese Cohort: Complication Risk Factor Analysis. Neurotherapeutics. 2021 Apr;18(2):1198-1206. doi: 10.1007/s13311-020-00990-8. Epub 2021 Jan 14.
- Background: PubMed 22859284O'Kelly CJ, Spears J, Chow M, Wong J, Boulton M, Weill A, Willinsky RA, Kelly M, Marotta TR. Canadian experience with the pipeline embolization device for repair of unruptured intracranial aneurysms. AJNR Am J Neuroradiol. 2013 Feb;34(2):381-7. doi: 10.3174/ajnr.A3224. Epub 2012 Aug 2.
- Background: PubMed 27739944Becske T, Potts MB, Shapiro M, Kallmes DF, Brinjikji W, Saatci I, McDougall CG, Szikora I, Lanzino G, Moran CJ, Woo HH, Lopes DK, Berez AL, Cher DJ, Siddiqui AH, Levy EI, Albuquerque FC, Fiorella DJ, Berentei Z, Marosfoi M, Cekirge SH, Nelson PK. Pipeline for uncoilable or failed aneurysms: 3-year follow-up results. J Neurosurg. 2017 Jul;127(1):81-88. doi: 10.3171/2015.6.JNS15311. Epub 2016 Oct 14.
- EDC system for patient randomization and data entryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. clinical and imaging data
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flow Diverter Group and Stent Assisted Coiling Group in people with Unruptured Intracranial Wide-neck Bifurcation Aneurysms, run by Nanfang Hospital, Southern Medical University 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 3 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 16 Jul 2026. 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?
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, MD (+8602062787842, kanghuibindoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of complications at 1 year postoperatively in patients treated with different modalities. (time frame: 1 year). 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 NCT07707076, which also lists 28 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 16 Jul 2026.