Early complications after flow diverter versus stent-assisted coiling for unruptured wide-neck intracranial bifurcation 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

This prospective, multicenter observational study collects data on adults with unruptured wide-neck intracranial bifurcation aneurysms treated with either a flow diverter or stent-assisted coiling at three centers in China. The primary outcome is a composite of any stroke or death within 30 days of the procedure. Researchers will gather demographic, clinical, imaging, and procedural information to compare early safety between the two treatments in routine practice. Follow-up is planned at 30 days to assess safety outcomes, with additional data on device use and perioperative management.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Voluntarily provides written informed consent.
* Aged 18 to 75 years.
* Diagnosed by CTA, MRA, or DSA as having an unruptured, bifurcation, saccular, wide-neck intracranial aneurysm.
* Able to understand the purpose of the study.

Exclusion Criteria:

* Patients with two or more multiple aneurysms, all of which require treatment within 1 year.
* Patients with other cerebrovascular diseases such as arteriovenous malformation or moyamoya disease.
* Patients with ruptured aneurysms or narrow-neck aneurysms.
* Patients who experienced stroke, including cerebral hemorrhage or cerebral infarction, within the past 1 month.
* Patients with poor clinical condition, defined as modified Rankin Scale score ≥3.
* Patients who have already planned to undergo surgical or interventional treatment within 3 months.
* Patients considered by the investigator to be unsuitable for endovascular treatment, such as those with no suitable vascular access, excessively tortuous vessels, or difficulty in stent delivery.
* Patients unsuitable for anesthesia or endovascular treatment, including those with major heart, lung, liver, spleen, or kidney disease, brain tumor, severe active infection, disseminated intravascular coagulation, or a history of severe psychiatric disorder.
* Patients unable to receive antiplatelet or anticoagulant therapy.
* Patients with a previous or possible severe reaction to contrast agents that would prevent completion of pre-treatment medication or treatment.
* Patients with a known history of allergy to cobalt-chromium or nickel-titanium alloy materials.
* Patients who participated in another drug or medical device clinical trial before enrollment and have not reached the time point of the primary endpoint.
* Pregnant or lactating women.
* Patients with life expectancy less than 12 months.
* Patients judged by the investigator to have poor compliance and inability to complete the study as required

Where it's running

• Nanfang Hospital, Southern Medical University
  Guangzhou, Guangdong, China Recruiting
• Guangdong Province People's Hospital
  Guangzhou, China Recruiting
• Zhujiang Hospital, Southern Medical University
  Guangzhou, China Recruiting

Study contacts

• Principal investigator: Wenfeng Feng, MD — Nanfang Hospital, Southern Medical University
• Study coordinator: Huibin Kang Study Contact, MD
• Email: kanghuibindoctor@163.com
• Phone: 13520296286

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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.