Registry of Endovascular Treatment for Vertebrobasilar Dissecting Aneurysms in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Poor prognosis
研究概览
简要总结
The incidence of vertebrobasilar dissecting aneurysms (VBDAs) is about 1/100,000~1.5/100,000, and it is one of the most important causes of stroke in young and middle-aged people. In recent years, with the development of medical imaging technology, the detection rate of this disease has been increasing year by year. The natural prognosis of VBDAs is complex and varied, with uncertainty: (1) it may have a benign course, and the imaging follow-up may show that the diseased vessels are repaired and improved or remain stable for a long period of time; (2) it may present with ischemic stroke caused by hemodynamic alteration or thromboembolism, which may result in severe neurological impairment; (3) it may occur as a result of rupture of aneurysms leading to subarachnoid hemorrhage, endangering the patient's life; (4) progressive enlargement of VBDAs causing occupying effects, which may be manifested as headache in mild cases, or hemiplegia of limbs and choking on drinking water in severe cases. Up to now, there is a lack of objective and uniform diagnostic and therapeutic guidelines for the natural regression of VBDAs and the benefits of surgery, and the treatment is mostly empirical, which makes it difficult to accurately determine the clinical prognosis of VBDAs and formulate appropriate treatment strategies.
Therefore, against the above background, we designed the present study. This study was a multicenter, prospective, registry study. We enrolled patients with unruptured VBDAs who met the inclusion and exclusion criteria, and a multi-disciplinary team formulated the treatment modalities for the patients, which were categorized into the conservative observation group, the stent-assisted coiling group, and the flow diverter group. The aim of our study was to investigate the effects of different treatment modalities on the prognosis of patients with VBDAs, as well as to stratify the risk factors of the patients, to explore the individualized treatment modalities of the patients, and to improve the diagnosis and treatment of this clinically refractory cerebrovascular disease.
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old;
- •Patients diagnosis of "unruptured vertebrobasilar dissecting aneurysm".
排除标准
- •Patients did not undergo a cranial MRI;
- •Missing critical clinical baseline;
- •Missing pre-treatment imaging;
- •Receiving microsurgery;
- •The combination of other serious diseases during diagnosis will significantly affect the follow-up of patients;
- •CT/MRI shows intracranial hemorrhage or subarachnoid hemorrhage (SWI microbleeds are ignored).
结局指标
主要结局
Poor prognosis
时间窗: 6 months, 1 year, 3 years, and 5 years after treatment.
Defined as an mRS score of 3-6.
Aneurysm rupture
时间窗: 6 months, 1 year, 3 years, and 5 years after treatment.
Severe headache developed after treatment and was confirmed by CT as subarachnoid hemorrhage associated with VBDAs.
次要结局
- VBDA-related death(6 months, 1 year, 3 years, and 5 years after treatment.)
- Ischemic stroke(6 months, 1 year, 3 years, and 5 years after treatment.)
- Compression symptom(6 months, 1 year, 3 years, and 5 years after treatment.)
- Rate of complete occlusion of aneurysms(6 months, 1 year, 3 years, and 5 years after treatment.)
- Aneurysm recanalization(6 months, 1 year, 3 years, and 5 years after treatment.)
- Improvement of neurological dysfunction(6 months, 1 year, 3 years, and 5 years after treatment.)
研究者
Ming Lv
MD
Beijing Tiantan Hospital
