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

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)

Conditions

• Unruptured Intracranial Wide-neck Bifurcation Aneurysms

Interventions

DEVICE

Flow Diverter Group

Flow diversion with the Pipeline™ (Flex/Shield) device for the treatment of unruptured intracranial bifurcation wide-necked aneurysms in the experimental group.

DEVICE

Stent Assisted Coiling Group

Stent-assisted coiling for the treatment of unruptured intracranial bifurcation wide-necked aneurysms in the control group.

Sponsors & Collaborators

• Shenzhen Second People's Hospital

  collaborator OTHER

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Liv Hospital Ankara

  collaborator OTHER

• ZhuHai Hospital

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Beijing Tiantan Hospital

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China

  collaborator UNKNOWN

• Guangdong Second Provincial People's Hospital

  collaborator UNKNOWN

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Xuanwu Hospital, Beijing

  collaborator OTHER

• Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand

  collaborator UNKNOWN

• Nanfang Hospital, Southern Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-10

Primary Completion

2027-06-30

Completion

2030-06-30

Countries

• China

Study Locations