Flow Diverter Versus Conventional Endovascular Treatment for Unruptured Wide-Neck Bifurcation Aneurysms (FD-BWA Trial)
Traditional Approach Versus Flow Diverter for Unruptured Intracranial Wide-neck Bifurcation Aneurysms: a Prospective International Multicenter Randomized Controlled Study (FD-BWA Study)
Nanfang Hospital, Southern Medical University
266 participants
Feb 10, 2026
INTERVENTIONAL
Conditions
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)
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
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 for the treatment of unruptured intracranial bifurcation wide-necked aneurysms in the control group.
Locations(1)
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NCT07707076