About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Flow Diverter Group
- Stent Assisted Coiling Group
Treatment groups
Sponsors and collaborators
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