New Covered Stent (Willis) for the Endovascular Reconstruction of Intracranial Vessel Wall Defects Registry
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 11
- 主要终点
- 1-year treatment success rate
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness, long-term safety and explore the safety and efficacy factors WILLIS™ intracranial stent graft system in clinical applications.
详细描述
Intracranial aneurysm is a cerebrovascular disorder in which weakness in the wall of a cerebral artery or vein causes a localized dilation or ballooning of the blood vessel.WILLIS® intracranial stent graft system is indicated for the treatment of intracranial aneurysms.
This study is a multi-center, prospective registration study.
Recruiting 100 specific patients to undergo a treatment with the WILLIS intracranial stent graft system, while giving the anti-platelet aggregation drugs and other medical therapy.
Patients enrolled will undergo a one-year follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18;
- •Arterial wall defects conformed by imaging examination due to internal carotid artery, vertebral artery aneurysms or various causes;
- •Target lesion vessel reference diameter 3.5-4.5mm;
- •Investigators believe that the patient is suitable for the interventional therapy of WILLIS intracranial covered stent;
- •Participate in the study voluntarily, accept follow up study and signed Informed Consent Form.
排除标准
- •Existence of branch artery (eg anterior choroidal artery, posterior communicating artery, posterior inferior cerebellar artery, etc.) of target lesion which may cause severe neurological dysfunction after occlusion;
- •No suitable vessel entrance, or diseased artery extremely tortuous;
- •Coagulation disorders or serious heart, liver, kidney dysfunction or systemic infection, which not suitable for interventional treatment;
- •Life expectancy <1 year;
- •Contraindications to heparin, aspirin, clopidogrel, anesthesia, X-ray or contrast agents;
- •Mental disorder
结局指标
主要结局
1-year treatment success rate
时间窗: 12 months
Treatment success is defined as target lesion such as aneurysms, cavernous fistula shows no shadow and target vessel stenosis of no more than 50%.
次要结局
- Target lesion treatment success rate(Immediately after surgery)
- X-ray exposure time(24 hours)
- Technically success rate of surgery(immediately after surgery)
- Target lesion was treated by interventional or surgical therapy once again(12 months)
- Postoperative ipsilateral symptomatic stroke(30 days; 6 months; 12 months)
- Operative time(through surgery completion)
- Surgery-related complications or death(12 months)
- All adverse events(12 months)
- Target lesion appears stenosis 12 months after surgery(12 months)
- Various causes of death(the perioperative period to 12 months)
- Recurrence of target lesion(12 months)
- Occurs intracranial hemorrhagic stroke that caused by aneurysm rupture(12 months)
- Occurs intracranial ischemic stroke that caused by thrombus(12 months)
- Device-related serious adverse events(12 months)
- NIHSS(30 days; 6 months; 12 months)
- Modified Rankin Scale(30 days; 6 months; 12 months)
研究者
Hongqi Zhang, MD
Cerebrovascular Expert Committee of Chinese Medical Doctor Association
Xuanwu Hospital, Beijing