Treatment Strategies for Unruptured Intracranial Aneurysms in the Chinese Population China Treatment Trial for Unruptured Intracranial Aneurysm (ChTUIA)

Unruptured Intracranial Aneurysm Clinical Trial

— ChTUIA  

Official title:

Treatment Strategies for Unruptured Intracranial Aneurysms in the Chinese Population China Treatment Trial for Unruptured Intracranial Aneurysm (ChTUIA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05844163
• Other study ID #: KY2022-226
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: November 1, 2024

Study information

• Verified date: April 2023
• Source: Beijing Tiantan Hospital
• Contact: Wang shuo, M.D.
• Phone: 13801180330
• Email: captain9858[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The goal of this prospective observational cohort study is to learn about treatment strategies for unruptured intracranial aneurysms in the Chinese population. The main questions it aims to answer are:

• To establish a cohort of patients with intracranial unruptured aneurysm and explore the optimal clinical treatment strategy.

• To establish clinical management path for patients with unruptured intracranial aneurysm.

According to the treatment of all patients with unruptured intracranial aneurysm, they were divided into the following groups: 1. Conservative treatment group; 2. Intracranial aneurysm clipping group; 3. Coil embolization or stent-assisted coil embolization group; 4. Flow diversion group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21041
• Est. completion date: November 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

A. age > 18 years. B. at least one intracranial aneurysm needs to be treated by craniotomy, endovascular treatment or combined surgery.

Exclusion Criteria:

1. Ruptured intracranial aneurysms, accompanied by subarachnoid hemorrhage or cerebral hemorrhage ;

2. Traumatic, infectious and atrial myxoma-associated intracranial aneurysms ;

3. Combined with cerebrovascular malformations ;

4. Combined with brain tumors or malignant tumors in other parts ;

5. with acute myocardial infarction ;

6. in acute or chronic heart failure ( New York Heart Association classification > 2 points ) ;

7. combined with systemic connective tissue disease and systemic rheumatic disease ;

8. Due to other diseases, or poor general condition, the expected survival time is not more than 12 months ;

9. during pregnancy and perinatal period

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Unruptured Intracranial Aneurysm

Intervention

Other:
• observation
observation

Locations

Country	Name	City	State
China	Capital Medical University Affiliated Beijing Tiantan Hospital	Beijing	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	First Affiliated Hospital of Fujian Medical University, Huashan Hospital, Shanxi Provincial People's Hospital, The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Outcome	Functional outcomes(modified Rankin Scale,mRS) at 2 years after treatment decision	2 years
Secondary	MACCE events	Incidence of major adverse cardiovascular/cerebrovascular events (MACCE events) in patients with atherosclerotic heart disease within 1 year after treatment decision.	1 years
Secondary	cardiovascular/cerebrovascular events	Incidence of cardiovascular/cerebrovascular events in 2 years after receiving different treatment strategies.	2 years
Secondary	Cost	Costs associated with unruptured intracranial aneurysms within 2 years after treatment with different strategies.	2 years
Secondary	Aneurysm-related bleeding events	Incidence of aneurysmal-related bleeding events within 2 years after receiving different treatment strategies.	2 years
Secondary	Mortality associated with intracranial aneurysms	Mortality associated with intracranial aneurysms within 2 years after treatment with different strategies	2 years
Secondary	All-cause mortality	All-cause mortality of patients within 2 years after different treatment strategies.	2 years