Flow diverter vs. stent-assisted coiling for unruptured wide-neck brain aneurysms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with unruptured wide-neck bifurcation intracranial aneurysms are randomly assigned to receive either a flow diverter or stent-assisted coiling. The study compares complications, stroke or death within one year, and long-term imaging results at 1, 2, and 5 years to assess safety and durability. Outcomes include procedure-related events, medical problems during follow-up, and imaging-based cure or stability over time. The trial is conducted at several hospitals in China with international collaboration. Eligibility targets adults 18–75 without recent ruptures or severe comorbidity.

Why it matters

Who can join: the full rules

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.

Where it's running

• Nanfang Hospital, Southern Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Huibin Kang, MD
• Email: kanghuibindoctor@163.com
• Phone: +8602062787842

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.