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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
266
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.
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGIncidence of complications at 1 year postoperatively in patients treated with different modalities.
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;
Time frame: 1 year
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.
Time frame: 5 years
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