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

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)

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.