Traditional Approach Versus Flow Diverter for Unruptured Intracranial Wide-neck Bifurcation Aneurysms: a Prospective International Multicenter Randomized Controlled Study (FD-BWA Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 266
- 试验地点
- 1
- 主要终点
- Incidence of complications at 1 year postoperatively in patients treated with different modalities.
研究概览
简要总结
Brief Summary：
The goal of this clinical trial is to compare whether the traditional approach (stent-assisted coiling) is associated with a lower complication rate than flow diverter (Pipeline™) treatment for unruptured intracranial wide-neck bifurcation aneurysms. It will also evaluate the long-term imaging outcomes and safety of both treatments. The main questions it aims to answer are:
- Does the traditional approach result in a lower rate of any stroke or all-cause death within one year after treatment compared to the flow diverter?
- What medical problems do participants experience during and after each treatment?
- What are the imaging cure and stability rates at 1, 2, and 5 years after treatment?
Researchers will compare the traditional approach (stent-assisted coiling) with the flow diverter (Pipeline™) to determine which treatment has better safety and efficacy outcomes.
Participants will:
- Be randomly assigned to receive either the flow diverter or traditional stent-assisted coiling
- Undergo the assigned endovascular procedure
- Return for follow-up visits at 30 days, 6 months, 1 year, 2 years, and 5 years after surgery for clinical assessments and imaging examinations (DSA, MRA, or CTA)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Age 18-75 years;
- •Diagnosis of unruptured intracranial, bifurcation, saccular, wide-neck aneurysm by DSA/CTA/MRA;
- •Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form.
排除标准
- •Patients with two or more multiple aneurysms that all require treatment within 1 year;
- •Concomitant cerebrovascular diseases such as arteriovenous malformation, moyamoya disease;
- •Ruptured aneurysms and narrow-neck aneurysms;
- •Patients who have had a stroke (cerebral hemorrhage, cerebral infarction) within the past 1 month;
- •Extremely poor clinical condition, modified Rankin Score ≥3;
- •Patients already scheduled for surgery/interventional procedure within 3 months;
- •Patients deemed unsuitable for interventional treatment by the investigator (e.g., no suitable vascular access, excessively tortuous vessels, difficulty delivering stent);
- •Patients unsuitable for anesthesia or endovascular surgery, such as major diseases of heart, lung, liver, spleen, kidney, brain tumors, severe active infections, disseminated intravascular coagulation, severe mental illness;
- •Patients unable to receive antiplatelet or anticoagulant therapy;
- •Patients who have had or may have severe reactions to contrast media precluding pre-treatment medication;
- •Patients with a definite history of allergy to cobalt-chromium, nickel-titanium alloy materials;
- •Participation in other drug or medical device clinical trials before enrollment without reaching the primary endpoint timeframe;
- •Pregnant or breastfeeding women;
- •Patient's life expectancy less than 12 months;
- •Investigator judges that the patient has poor compliance and cannot complete the study as required.
结局指标
主要结局
Incidence of complications at 1 year postoperatively in patients treated with different modalities.
时间窗: 1 year
Any stroke, all-cause death events within 1 year post-surgery. Definitions: 1. Stroke defined as: acute focal or global neurological dysfunction due to vascular injury of brain, spinal cord or retina caused by hemorrhage or infarction, symptom duration ≥24 hours, including symptomatic branch stenosis/occlusion due to branch coverage; 2. TIA: transient focal neurological dysfunction due to brain, spinal cord or retinal ischemia, symptom duration \<24 hours, without acute infarction;
次要结局
- Aneurysm occlusion rate and stability rate after different treatment modalities.(5 years)