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)
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.
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;
Parallel
Flow Diverter Group
DeviceFlow 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
DeviceStent-assisted coiling for the treatment of unruptured intracranial bifurcation wide-necked aneurysms in the control group.
Incidence 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;
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.
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Nanfang Hospital, Southern Medical University
Lead sponsor
Shenzhen Second People's Hospital
Collaborator
Guangdong Provincial People's Hospital
Collaborator
Liv Hospital Ankara
Collaborator
ZhuHai Hospital
Collaborator
West China Hospital
Collaborator
Beijing Tiantan Hospital
Collaborator
Henan Provincial People's Hospital
Collaborator
Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China
Collaborator
Guangdong Second Provincial People's Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Xuanwu Hospital, Beijing
Collaborator
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Collaborator
