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NCT Number: NCT07707076

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Extremely poor clinical condition, modified Rankin Score ≥3;
  • Patients already scheduled for surgery/interventional procedure within 3 months;
  • Patients deemed unsuitable for interventional treatment by the investigator (e.g., no suitable vascular access, excessively tortuous vessels, difficulty delivering stent);
  • 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;
  • Patients unable to receive antiplatelet or anticoagulant therapy;
  • Patients who have had or may have severe reactions to contrast media precluding pre-treatment medication;
  • Patients with a definite history of allergy to cobalt-chromium, nickel-titanium alloy materials;
  • Participation in other drug or medical device clinical trials before enrollment without reaching the primary endpoint timeframe;
  • Pregnant or breastfeeding women;
  • Patient's life expectancy less than 12 months;
  • Investigator judges that the patient has poor compliance and cannot complete the study as required.

Treatment and study plan

Flow Diverter Group

Device

Flow 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

Device

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

Primary outcomes

  1. 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:

    • 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;
    • TIA: transient focal neurological dysfunction due to brain, spinal cord or retinal ischemia, symptom duration <24 hours, without acute infarction;

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Huibin Kang, MD

CONTACT

[email protected]

+8602062787842

Wenfeng Feng, MD

CONTACT

[email protected]

+8602062787665

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: FD-BWA

Important dates

Study start
2026
Primary completion
2027
Study completion
2030
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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