💬In plain words
What the trial is, and whether it could suit you
This prospective real-world cohort study aims to compare early postoperative complications between flow diverter treatment and stent-assisted coiling in patients with unruptured wide-neck intracranial bifurcation aneurysms. A total of 274 patients from three centers in China will be enrolled and assigned to the flow diverter group or the stent-assisted coiling group according to the treatment received in routine clinical practice. The primary outcome is a composite of any stroke or all-cause death within 30 days after the procedure. The study will also collect demographic, clinical, laboratory, imaging, aneurysm morphological, procedural, and follow-up data to evaluate the safety of these two endovascular treatment strategies in a real-world setting.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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