Early Complications After Flow Diverter Versus Stent-Assisted Coiling for Unruptured Wide-Neck Intracranial Bifurcation Aneurysms: A Prospective Real-World Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 274
- 试验地点
- 3
- 主要终点
- Composite incidence of any stroke or all-cause death within 30 days after procedure
研究概览
简要总结
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.
详细描述
Intracranial bifurcation aneurysms are common and are challenging to treat because of their complex anatomy. Flow diverters have emerged as an innovative endovascular therapy and have shown preliminary efficacy in bifurcation aneurysms. However, compared with conventional stent-assisted coiling, real-world evidence regarding early postoperative complication risks and related influencing factors remains limited.
This study will establish a prospective multicenter real-world database to compare the incidence of early complications after treatment with a flow diverter versus stent-assisted coiling in patients with unruptured wide-neck intracranial bifurcation aneurysms. Eligible patients who provide informed consent and meet the inclusion and exclusion criteria will be enrolled from three centers in China. Patients treated with a flow diverter will enter the flow diverter group, and patients treated with stent-assisted coiling will enter the stent-assisted coiling group.
All patients will undergo preoperative evaluation, perioperative management, postoperative antiplatelet therapy, and follow-up according to clinical practice and relevant guidelines. Data collected will include demographic characteristics, medical history, physical examination, laboratory tests, imaging findings, aneurysm morphology, procedural details, device information, medication history, and adverse events. Follow-up will be performed at 30 days after treatment to assess safety outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 ≥
- •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
研究组 & 干预措施
Flow Diverter Group
Patients with unruptured wide-neck intracranial bifurcation aneurysms who receive flow diverter treatment in routine clinical practice.
干预措施: Flow Diverter (Device)
Stent-Assisted Coiling Group
Patients with unruptured wide-neck intracranial bifurcation aneurysms who receive stent-assisted coiling in routine clinical practice.
干预措施: Stent-Assisted Coiling (Device)
结局指标
主要结局
Composite incidence of any stroke or all-cause death within 30 days after procedure
时间窗: Within 30 days after procedure
The primary outcome is the occurrence of any stroke or all-cause death within 30 days after the endovascular procedure. Stroke is defined as an acute onset of focal or global neurological dysfunction caused by vascular injury of the brain, spinal cord, or retina due to hemorrhage or infarction, with symptoms lasting 24 hours or longer.
次要结局
- Incidence of all-cause death within 30 days after procedure(Within 30 days after procedure)
- Incidence of any stroke within 30 days after procedure(Within 30 days after procedure)
- Incidence of transient ischemic attack within 30 days after procedure(Within 30 days after procedure)
- Incidence of adverse events and serious adverse events within 30 days after procedure(Within 30 days after procedure)
研究者
Feng wen feng
Principal Investigator
Nanfang Hospital, Southern Medical University