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

July 10, 2026 updated by: Nanfang Hospital, Southern Medical University

Traditional Approach Versus Flow Diverter for Unruptured Intracranial Wide-neck Bifurcation Aneurysms: a Prospective International Multicenter Randomized Controlled Study (FD-BWA Study)

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

266

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital, Southern Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18-75 years;
  2. Diagnosis of unruptured intracranial, bifurcation, saccular, wide-neck aneurysm by DSA/CTA/MRA;
  3. Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form.

Exclusion Criteria:

  1. Patients with two or more multiple aneurysms that all require treatment within 1 year;
  2. Concomitant cerebrovascular diseases such as arteriovenous malformation, moyamoya disease;
  3. Ruptured aneurysms and narrow-neck aneurysms;
  4. Patients who have had a stroke (cerebral hemorrhage, cerebral infarction) within the past 1 month;
  5. Extremely poor clinical condition, modified Rankin Score ≥3;
  6. Patients already scheduled for surgery/interventional procedure within 3 months;
  7. Patients deemed unsuitable for interventional treatment by the investigator (e.g., no suitable vascular access, excessively tortuous vessels, difficulty delivering stent);
  8. Patients unsuitable for anesthesia or endovascular surgery, such as major diseases of heart, lung, liver, spleen, kidney, brain tumors, severe active infections, disseminated intravascular coagulation, severe mental illness;
  9. Patients unable to receive antiplatelet or anticoagulant therapy;
  10. Patients who have had or may have severe reactions to contrast media precluding pre-treatment medication;
  11. Patients with a definite history of allergy to cobalt-chromium, nickel-titanium alloy materials;
  12. Participation in other drug or medical device clinical trials before enrollment without reaching the primary endpoint timeframe;
  13. Pregnant or breastfeeding women;
  14. Patient's life expectancy less than 12 months;
  15. Investigator judges that the patient has poor compliance and cannot complete the study as required.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Stent Assisted Coiling Group

Traditional Group (Stent Assisted Coiling):

The patient is placed in a supine position. After satisfactory general anesthesia, the right groin area is routinely disinfected and draped. The right femoral artery sheath is replaced with an 8F sheath. Systemic heparinization is administered, followed by continuous pressurized infusion. A 6F long sheath plus a 5F multifunction catheter are advanced with a Terumo guidewire, and the long sheath is positioned in the left vertebral artery. A micro guidewire is used with a microcatheter to selectively catheterize the left posterior cerebral artery P2 segment, and then the microcatheter is advanced into the aneurysm. Through the microcatheter, one coil is semi deployed to form a framing coil, then one stent is deployed through the stent catheter to cover the aneurysm neck. After the first framing coil is detached, several additional coils are sequentially deployed to embolize the aneurysm. Follow up angiography shows no opacification of the a
Device: Stent Assisted Coiling Group
Stent-assisted coiling for the treatment of unruptured intracranial bifurcation wide-necked aneurysms in the control group.
Experimental: Flow Diverter Group

Flow Diverter Group:

The patient is placed in a supine position. The right groin area is routinely disinfected and draped. Local infiltration anesthesia is applied at the puncture site, and the right femoral artery is punctured using the Seldinger technique. An 8F sheath is inserted, systemic heparinization is administered, and continuous pressurized infusion is started. A 6F long sheath is advanced to the origin of the right internal carotid artery with the assistance of a Terumo guidewire and a multifunction catheter. A 5F intermediate catheter is advanced inside the long sheath to the petrous segment of the right internal carotid artery. 3D cerebral angiography is performed, and after a suitable working angle is obtained, a stent catheter is advanced to the right middle cerebral artery M3 segment with micro guidewire assistance. Manual injection shows no hemorrhage, confirming the true lumen. After calibration and measurement, one flow diverter stent is deployed to cover the ane
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of complications at 1 year postoperatively in patients treated with different modalities.
Time Frame: 1 year

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;
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aneurysm occlusion rate and stability rate after different treatment modalities.
Time Frame: 5 years

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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital, Southern Medical University

Collaborators

Beijing Tiantan Hospital
West China Hospital
Xuanwu Hospital, Beijing
The First Affiliated Hospital of Zhengzhou University
Guangdong Provincial People's Hospital
Henan Provincial People's Hospital
Shenzhen Second People's Hospital
ZhuHai Hospital
Zhujiang Hospital, Southern Medical University, Guangzhou, Guangdong, China
Liv Hospital Ankara
Guangdong Second Provincial People's Hospital
Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2030

Study Registration Dates

First Submitted

March 29, 2026

First Submitted That Met QC Criteria

July 10, 2026

First Posted (Actual)

July 16, 2026

Study Record Updates

Last Update Posted (Actual)

July 16, 2026

Last Update Submitted That Met QC Criteria

July 10, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2025-738

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

clinical and imaging data

IPD Sharing Time Frame

2025.06.01-2030.06.31

IPD Sharing Access Criteria

Principal Investigators at each study center

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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