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

NCT04927520 | Unknown

• 1 other identifier: 2019-174
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Middle cerebral artery aneurysms; Clipping surgery; Coil embolization; Endovascular therapy; Unruptured aneurysm

Outcome Measures

Primary Outcomes (2)

• mRS at 3 months

  the favorable outcome was defined as mRS 0-2

  at 3 months

• Complication

  including aneurysm rupture, aneurysm recurrence, stroke and other cerebrovascular disease

  during hospitalization up to 14 days

Study Arms (2)

Endovascular therapy group

Unruptured middle cerebral artery aneurysms treated with coil embolization

Clipping surgery group

Unruptured middle cerebral artery aneurysms treated with clipping surgery

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed unruptured middle artery aneurysm and treated with coil embolization or endovascular therapy

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• Jinhua Central Hospital: collaborator
• Ningbo No. 1 Hospital: collaborator
• The Central Hospital of Lishui City: collaborator
• Taizhou Hospital: collaborator
• People's Hospital of Quzhou: collaborator

Study Sites (1)

the Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Xu Jing

CONTACT

+86-13958119687; jingxu@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2021
• First Posted: June 16, 2021
• Study Start: June 5, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 16, 2021

Record last verified: 2021-06

Locations

CN (1)