Traditional Approach Versus Flow Diverter for Unruptured Intracranial Wide-neck Bifurcation Aneurysms: a Prospective International Multicenter Randomized Controlled Study (FD-BWA Study)
| Registry | NCT07707076, acronym FD-BWA |
|---|
| Status | Recruiting |
|---|
| Phase | Not applicable |
|---|
| Study type | Interventional; randomized, parallel, masking: single, treatment |
|---|
| Enrollment | 266 (Estimated) |
|---|
| Sponsor | Nanfang Hospital, Southern Medical University (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 |
|---|
| Conditions | Unruptured Intracranial Wide-neck Bifurcation Aneurysms |
|---|
| Interventions | Flow Diverter Group, Stent Assisted Coiling Group (Device) |
|---|
| Dates | start 2026-02-10, primary completion 2027-06-30 (estimated), completion 2030-06-30 (estimated), first posted 2026-07-16, last updated 2026-07-16 |
|---|
| Locations | 1 site in China |
|---|
Related Papers Related Patents Related Grants Related Experts
All trials for Unruptured Intracranial Wide-neck Bifurcation Aneurysms All trials of Flow Diverter Group All trials of Stent Assisted Coiling Group
-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. 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)
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Stent Assisted Coiling Group | Active comparator | Device: Stent Assisted Coiling Group | 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 |
| Flow Diverter Group | Experimental | Device: Flow Diverter Group | 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 |
- Flow Diverter Group (Device): 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 Group (Device): Stent-assisted coiling for the treatment of unruptured intracranial bifurcation wide-necked aneurysms in the control group.
+Outcome measures
Primary outcomes
- Incidence of complications at 1 year postoperatively in patients treated with different modalities. [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;
Secondary outcomes
- Aneurysm occlusion rate and stability rate after different treatment modalities. [5 years]: 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.
+Eligibility
Sex: All, ages: 18 Years to 75 Years
Inclusion Criteria:
1. Age 18-75 years;
2. Diagnosis of unruptured intracranial, bifurcation, saccular, wide-neck aneurysm by DSA/CTA/MRA;
3. Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form.
Exclusion Criteria:
1. Patients with two or more multiple aneurysms that all require treatment within 1 year;
2. Concomitant cerebrovascular diseases such as arteriovenous malformation, moyamoya disease;
3. Ruptured aneurysms and narrow-neck aneurysms;
4. Patients who have had a stroke (cerebral hemorrhage, cerebral infarction) within the past 1 month;
5. Extremely poor clinical condition, modified Rankin Score ≥3;
6. Patients already scheduled for surgery/interventional procedure within 3 months;
7. Patients deemed unsuitable for interventional treatment by the investigator (e.g., no suitable vascular access, excessively tortuous vessels, difficulty delivering stent);
8. 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;
9. Patients unable to receive antiplatelet or anticoagulant therapy;
10. Patients who have had or may have severe reactions to contrast media precluding pre-treatment medication;
11. Patients with a definite history of allergy to cobalt-chromium, nickel-titanium alloy materials;
12. Participation in other drug or medical device clinical trials before enrollment without reaching the primary endpoint timeframe;
13. Pregnant or breastfeeding women;
14. Patient's life expectancy less than 12 months;
15. Investigator judges that the patient has poor compliance and cannot complete the study as required.
+Locations (1)
| Facility | City | Country | Status |
|---|
| Nanfang Hospital, Southern Medical University | Guangzhou, Guangdong | China | Recruiting |
+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. PMID 27226859
- Brinjikji 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. PMID 23321438
- Cekirge 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. PMID 26316566
- Byoun 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. PMID 39002303
- Saleme 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. PMID 25121791
- Salem 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. PMID 34732531
- Iosif 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. PMID 27979794
- Limbucci 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. PMID 31838532
- Luo 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. PMID 33224273
- Kang 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. PMID 33447904
- O'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. PMID 22859284
- Becske 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. PMID 27739944
- Becske 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. PMID 23418004
- Jiang 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. PMID 17615366
- Gao BL, Hao H, Hao W, Ren CF, Yang L, Han Y. Cerebral aneurysms at major arterial bifurcations are associated with the arterial branch forming a smaller angle with the parent artery. Sci Rep. 2022 Mar 24;12(1):5106. doi: 10.1038/s41598-022-09000-7. PMID 35332228
- Hetts SW. Back to the Future: A Mesh Balloon for Wide-necked Brain Aneurysm Endovascular Treatment. Radiology. 2022 Aug;304(2):383-384. doi: 10.1148/radiol.213306. Epub 2022 Apr 19. No abstract available. PMID 35438570
- Kuwajima T, Kazekawa K, Maruyama K, Yoshida S, Hama Y, Morita H, Ota Y, Tashiro N, Hiraoka F, Kawano H, Yano S, Aikawa H, Go Y, Yoshimura S. Usefulness and problems of Y-Stent and T-Stent assisted coiling for unruptured cerebral aneurysms. J Stroke Cerebrovasc Dis. 2022 Oct;31(10):106668. doi: 10.1016/j.jstrokecerebrovasdis.2022.106668. Epub 2022 Aug 18. PMID 35986945
- Chung J, Park W, Park JC, Kwun BD, Ahn JS. Characteristics of Peri-Internal Carotid Artery Bifurcation Aneurysms According to a New Anatomic Classification: How to Overcome Difficulties in the Microsurgical Treatment of Posteroinferiorly Projecting Carotid-A1 Junctional Aneurysms. World Neurosurg. 2019 Jun;126:e1219-e1227. doi: 10.1016/j.wneu.2019.02.232. Epub 2019 Mar 16. PMID 30885871
- Narata AP, de Moura FS, Larrabide I, Perrault CM, Patat F, Bibi R, Velasco S, Januel AC, Cognard C, Chapot R, Bouakaz A, Sennoga CA, Marzo A. The Role of Hemodynamics in Intracranial Bifurcation Arteries after Aneurysm Treatment with Flow-Diverter Stents. AJNR Am J Neuroradiol. 2018 Feb;39(2):323-330. doi: 10.3174/ajnr.A5471. Epub 2017 Nov 23. PMID 29170270
- Campos JK, Lien BV, Wang AS, Lin LM. Advances in endovascular aneurysm management: coiling and adjunctive devices. Stroke Vasc Neurol. 2020 Mar 15;5(1):14-21. doi: 10.1136/svn-2019-000303. eCollection 2020. PMID 32411403
- van der Kamp LT, Rinkel GJE, Verbaan D, van den Berg R, Vandertop WP, Murayama Y, Ishibashi T, Lindgren A, Koivisto T, Teo M, St George J, Agid R, Radovanovic I, Moroi J, Igase K, van den Wijngaard IR, Rahi M, Rinne J, Kuhmonen J, Boogaarts HD, Wong GKC, Abrigo JM, Morita A, Shiokawa Y, Hackenberg KAM, Etminan N, van der Schaaf IC, Zuithoff NPA, Vergouwen MDI. Risk of Rupture After Intracranial Aneurysm Growth. JAMA Neurol. 2021 Oct 1;78(10):1228-1235. doi: 10.1001/jamaneurol.2021.2915. PMID 34459846
- Alfano JM, Kolega J, Natarajan SK, Xiang J, Paluch RA, Levy EI, Siddiqui AH, Meng H. Intracranial aneurysms occur more frequently at bifurcation sites that typically experience higher hemodynamic stresses. Neurosurgery. 2013 Sep;73(3):497-505. doi: 10.1227/NEU.0000000000000016. PMID 23756745
- GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3. PMID 34487721
- Sharma D. Perioperative Management of Aneurysmal Subarachnoid Hemorrhage. Anesthesiology. 2020 Dec 1;133(6):1283-1305. doi: 10.1097/ALN.0000000000003558. PMID 32986813
- Tawk RG, Hasan TF, D'Souza CE, Peel JB, Freeman WD. Diagnosis and Treatment of Unruptured Intracranial Aneurysms and Aneurysmal Subarachnoid Hemorrhage. Mayo Clin Proc. 2021 Jul;96(7):1970-2000. doi: 10.1016/j.mayocp.2021.01.005. Epub 2021 May 13. PMID 33992453
- Results publication: Cagnazzo 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. PMID 30523146
- Results publication: Kashkoush 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. PMID 37541838
+Study documents