Prospective, Multicenter Cohort Study on the Safety and Efficacy of Treatment for Middle Cerebral Artery Aneurysms

Summary

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.

Conditions

• Middle Cerebral Artery Aneurysm

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Jinhua Central Hospital

  collaborator OTHER

• Ningbo No. 1 Hospital

  collaborator OTHER

• The Central Hospital of Lishui City

  collaborator OTHER

• Taizhou Hospital

  collaborator OTHER

• People's Hospital of Quzhou

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Eligibility

Min Age

14 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-05

Primary Completion

2024-12-31

Completion

2024-12-31

Countries

• China

Study Locations