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

NCT05844163 | Completed DMC

• 1 other identifier: KY2022-226
• Study Type: observational
• Target: 31,595
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unruptured Intracranial Aneurysm

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  Functional outcomes(modified Rankin Scale,mRS) at 2 years after treatment decision

  2 years

Secondary Outcomes (6)

• MACCE events

  1 years

• cardiovascular/cerebrovascular events

  2 years

• Cost

  2 years

• Aneurysm-related bleeding events

  2 years

• Mortality associated with intracranial aneurysms

  2 years

Study Arms (3)

Intracranial aneurysm clipping group

Patients in Intracranial aneurysm clipping group receive neurosurgical clipping.

Other: observation

Coil embolization or stent-assisted coil embolization group

Patients in coil embolization or stent-assisted coil embolization group receive coil embolization or stent-assisted coil embolization according to individualized condition.

Other: observation

Flow diversion group.

Patients in flow diversion group receive flow diverters.

Other: observation

Interventions

observation OTHER

observation

Coil embolization or stent-assisted coil embolization group; Flow diversion group.; Intracranial aneurysm clipping group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with unruptured intracranial aneurysm

You may qualify if:

• A. age \> 18 years. B. at least one intracranial aneurysm needs to be treated by craniotomy, endovascular treatment or combined surgery.
• C. patients' consent were obtained.

You may not qualify if:

• Ruptured intracranial aneurysms, accompanied by subarachnoid hemorrhage or cerebral hemorrhage ;
• Traumatic, infectious and atrial myxoma-associated intracranial aneurysms ;
• Combined with cerebrovascular malformations;
• Combined with brain tumors or malignant tumors in other parts ;
• Combined with systemic connective tissue disease and systemic rheumatic disease ;
• Due to other diseases, or poor general condition, the expected survival time is not more than 12 months ;
• During pregnancy and perinatal period.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Huashan Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• First Affiliated Hospital of Fujian Medical University: collaborator
• Shanxi Provincial People's Hospital: collaborator

Study Sites (1)

Capital Medical University Affiliated Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

• Zheng K, Wen Z, Wang K, Mo S, Wu J, Chen X, Zhao B, Liu Q, Wang S. Treatment strategies for unruptured intracranial aneurysms in the Chinese population: China Treatment Trial for Unruptured Intracranial Aneurysm (ChTUIA). Chin Neurosurg J. 2025 Apr 3;11(1):8. doi: 10.1186/s41016-025-00394-7.

  PMID: 40181400 DERIVED

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Wang shuo, M.D.

  Beijing Tiantan Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Cerebrovascular Neurosurgery

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: December 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)