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

Recruiting now · Not applicable

Conditions studied: Unruptured Intracranial Wide-neck Bifurcation Aneurysms

In brief

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)

Key facts

Study ID

NCT07707076

Run by

Nanfang Hospital, Southern Medical University

People needed

266

Starts

2026-02-10

Expected to finish

2030-06-30

Last updated by the study team

2026-07-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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