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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNanfang Hospital, Southern Medical University

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

266 Participants
are divided into 2 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