Clinical Trial

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

Study acronym: FD-BWA
Recruiting
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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)
Trial Details
NCT Number NCT07707076
Lead Sponsor Nanfang Hospital, Southern Medical University
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
Enrollment 266 participants
Start Date 2026-02-10
Primary Completion 2027-06-30 (estimated)
Study Completion 2030-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-16