Safety and Efficacy of Treatment for Middle Cerebral Artery Aneurysms: a Prospective and Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- mRS at 3 months
研究概览
简要总结
Intracranial aneurysm is one of the most common cerebrovascular diseases, with a prevalence of about 3.2%. With the aging of the population and the further popularization of MRA and other examination methods, the prevalence of intracranial aneurysm will further increase. Rupture of intracranial aneurysm is an important cause of death and severe disability in patients. The annual rate of rupture of intracranial aneurysm is about 1%, and the size of aneurysm, the location of aneurysm in the posterior circulation, and the history of subarachnoid hemorrhage on the aneurysm wall are the risk factors for aneurysm rupture. Phases are currently recognized tools for assessing the risk of aneurysm rupture, which can provide important guidance for neurosurgeons and patients to decide whether to actively intervene. In the last century, for patients with intracranial aneurysm with high risk of rupture, craniotomy and clipping for intracranial aneurysm was the gold standard for treatment.
However, with the rapid development of embolization technology and materials in the past 20 years, the application of endovascular embolization for intracranial aneurysms has been more and more widely, especially after several large prospective studies such as ISAT and ISUIA, endovascular embolization has more advantages over craniotomy clipping.Whereas, it is still very popular to adopt craniotomy clipping for middle cerebral artery aneurysms, the main reasons for which are relative superficial location, wider aneurysm neck, smaller parent artery and more branching vessels, etc., which make early endovascular embolization treatment not advantageous. With the maturity of stent-assisted embolization technology in recent years, the use of a new generation of stents, and the improvement of perioperative anti-platelet strategies, endovascular embolization has achieved good results in the treatment of middle artery aneurysms. However, these studies were retrospective, single-center studies, subject to a variety of confounding factors, and the reliability of the results is limited.
Therefore, it will be of great clinical significance to carry out a prospective, multi-center clinical study on the treatment strategy of middle cerebral artery aneurysms.
Patients with unruptured middle cerebral artery aneurysms who had been diagnosed with at least one imaging （CTA/MRA/DSA）were enrolled. The treatment including endovascular embolization and craniotomy clipping was determined according to routine management in the center. After receiving informed consent from the patients, the safety and effectiveness data were obtained to verify whether endovascular embolization was safe and effective. Through further follow-up and data analysis, protective factors and risk factors for the treatment of middle cerebral artery aneurysms were investigated. Through well-designed clinical studies, safer and more effective treatment methods can be found, and potential factors leading to perioperative complications can be found, ultimately improving the prognosis of patients with middle cerebral artery aneurysms.
详细描述
- Data collection and management A unified and open public health platform will be established, and data will be centrally recorded in each central unit for verification by inspectors. An open network data platform for intracranial aneurysm research was established by the management personnel of different qualification levels. In order to ensure the advancement and sustainable development of the data platform construction, a public research platform for intracranial aneurysms shared in the province was built by using the keywords and retrieval items commonly used in China.
After researcher training and standardized study of the scheme, the formal trial was started. A team of experts will be selected to form an inspection team, which will initiate visits to each organization and conduct the first inspection visit as soon as possible after screening the first subject. Regular monitoring visits are required until the end of the experiment. All the data were collected according to the electronic medical record (CRF) form, and then the aneurysm data (EDC) was managed according to the CRF form, and the accuracy and rigor of the data were checked in time.
This study establishes a management committee, including clinical experts, evidence-based medicine experts, and CRO clinical study supervisors, who are responsible for project design, task formulation, supervision of project implementation, data analysis and formulation of standards and guidelines.
The central laboratory and imaging interpretation center were established to carry out unified standard central storage for clinical specimens. The unified image and laboratory technology platform can be used for the image examination and post-processing technology in the project. Uniform standard interpretation of imaging data was carried out. A unified, standardized and efficient transmission mechanism for clinical specimens, data and data in each center was established.
Establish a data management committee, set up a network data platform and be responsible for the construction and maintenance of the database, conduct real-time supervision on the quality of the input data, ensure the safety, integrity and accuracy of the data, establish and organize the implementation of the platform or offline dual-channel error correction and reminder mechanism. Set and manage the rights of all project participants on the data platform, monitor and record the data entry, modification and retrieval, set and manage the data publication of the open platform. Contact and consult statistical experts to conduct periodic analysis of data results and generate research reports.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 1 middle cerebral artery aneurysm confirmed by imaging (CTA/MRA/DSA);
- •Accept endovascular intervention or middle cerebral artery aneurysm clip craniotomy, regardless of whether there is a clinical symptoms;
- •Multiple aneurysms, whether usual treatment, but it requires the treatment time interval to > 6 months;
- •The subjects currently has independent life ability, namely the mRS score 3 points or less;
- •The patient or family agreed to sign a consent form.
排除标准
- •Patients with other intracranial vascular malformations, such as AVM and AVF;
- •Fusiform, traumatic, bacterial or dissecting aneurysm;
- •Ruptured middle cerebral artery aneurysm associated with intracranial hematoma;
- •Intracranial or other parts of the patients with malignant tumors;
- •General condition is bad, is expected to survival time less than 1 year or poor body condition, can't tolerate anesthesia or aneurysm surgery patients;
- •Involved with other intracranial aneurysm patients clinical research;
- •A hospital surgery clip or endovascular treatment of patients at the same time;
- •Refused to follow-up of patients.
结局指标
主要结局
mRS at 3 months
时间窗: at 3 months
the favorable outcome was defined as mRS 0-2
Complication
时间窗: during hospitalization up to 14 days
including aneurysm rupture, aneurysm recurrence, stroke and other cerebrovascular disease
次要结局
未报告次要终点