NCT07754188Recruiting
Early Complications After Flow Diverter Versus Stent-Assisted Coiling for Unruptured Wide-Neck Intracranial Bifurcation Aneurysms
Early Complications After Flow Diverter Versus Stent-Assisted Coiling for Unruptured Wide-Neck Intracranial Bifurcation Aneurysms: A Prospective Real-World Cohort Study
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 274 (estimated)
- First submitted
- 4 Aug 2026
- Start date
- 19 Mar 2026
- Primary completion date
- 19 Mar 2027
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- Stroke
- NCT number
- NCT07754188
What you commit to
- Study type: Observational
- Planned participants: 274
- From 19 Mar 2026 to the primary completion date, 19 Mar 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have already planned to undergo surgical or interventional treatment within 3 months.
- 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 who participated in another drug or medical device clinical trial before enrollment and have not reached the time point of the primary endpoint.
Other illness
- Patients with other cerebrovascular diseases such as arteriovenous malformation or moyamoya disease.
- 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 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 with a known history of allergy to cobalt-chromium or nickel-titanium alloy materials.
Other
- Patients with two or more multiple aneurysms, all of which require treatment within 1 year.
- Patients with ruptured aneurysms or narrow-neck aneurysms.
- 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.
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhujiang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Guangdong Province People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.