Flow Diverter Versus Conventional Endovascular Treatment for Unruptured Wide-Neck Bifurcation Aneurysms (FD-BWA Trial)

Official title

Traditional Approach Versus Flow Diverter for Unruptured Intracranial Wide-neck Bifurcation Aneurysms: a Prospective International Multicenter Randomized Controlled Study (FD-BWA Study)

Overview

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)

Interventions

• Device Flow Diverter Group
  Flow diversion with the Pipeline™ (Flex/Shield) device for the treatment of unruptured intracranial bifurcation wide-necked aneurysms in the experimental group.
• Device Stent Assisted Coiling Group
  Stent-assisted coiling for the treatment of unruptured intracranial bifurcation wide-necked aneurysms in the control group.

Primary outcome measures

• Incidence of complications at 1 year postoperatively in patients treated with different modalities. [Time frame: 1 year]

Secondary outcome measures (1)

• Aneurysm occlusion rate and stability rate after different treatment modalities. [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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;
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• Nanfang Hospital, Southern Medical University — Guangzhou

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 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

Identifiers

NCT: NCT07707076 · NFEC-2025-738

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗