No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 – 75
Sex
Any
Study type
Observational
Participants needed
274 (estimated)
Sponsor
Nanfang Hospital, Southern Medical University · Other
Who this trial is looking for
This trial is looking for people aged 18 to 75 who have a specific type of brain aneurysm that hasn't burst. Participants will be assigned to receive either a flow diverter or stent-assisted coiling treatment and will be monitored for complications after the procedure.
Are You a Good Fit for This Trial?
Rules you outMoyamoya diseaseArteriovenous malformation
You may be able to join if
I am aged 18 to 75
I have been diagnosed with a wide-neck bifurcation aneurysm
I can provide written consent
I understand the purpose of the study
You may not be able to join if
I have two or more aneurysms that need treatment within a year
I have a past stroke or brain hemorrhage in the last month
I am in poor clinical condition
I have a brain tumor or severe infection
I cannot receive antiplatelet or anticoagulant therapy
I have had a severe reaction to contrast agents
I am pregnant or breastfeeding
I have a life expectancy of less than 12 months
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 rece…
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.
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Eligibility Criteria
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 mo…
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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