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NCT Number: NCT05844163

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

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.

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Key information

Conditions

Unruptured Intracranial Aneurysm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Capital Medical University Affiliated Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

  • 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.

Treatment and study plan

observation

Other

observation

Primary outcomes

  1. Primary Outcome

    Time frame: 2 years

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

Secondary outcomes

  1. MACCE events

    Time frame: 1 years

    Incidence of major adverse cardiovascular/cerebrovascular events (MACCE events) in patients with atherosclerotic heart disease within 1 year after treatment decision.

  2. cardiovascular/cerebrovascular events

    Time frame: 2 years

    Incidence of cardiovascular/cerebrovascular events in 2 years after receiving different treatment strategies.

  3. Cost

    Time frame: 2 years

    Costs associated with unruptured intracranial aneurysms within 2 years after treatment with different strategies.

  4. Aneurysm-related bleeding events

    Time frame: 2 years

    Incidence of aneurysmal-related bleeding events within 2 years after receiving different treatment strategies.

  5. Mortality associated with intracranial aneurysms

    Time frame: 2 years

    Mortality associated with intracranial aneurysms within 2 years after treatment with different strategies

  6. All-cause mortality

    Time frame: 2 years

    All-cause mortality of patients within 2 years after different treatment strategies.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Anhui Provincial Hospital
  • Beijing Chao Yang Hospital
  • Beijing Friendship Hospital
  • Beijing Hospital
  • Binzhou Medical University
  • Changhai Hospital
  • Chinese PLA General Hospital
  • Chongqing General Hospital
  • First Affiliated Hospital Xi'an Jiaotong University
  • First Affiliated Hospital of Chongqing Medical University
  • First Affiliated Hospital of Fujian Medical University
  • First Affiliated Hospital of Guangxi Medical University
  • First Affiliated Hospital of Harbin Medical University
  • First Affiliated Hospital of Kunming Medical University
  • First Affiliated Hospital of Xinjiang Medical University
  • First Affiliated Hospital, Sun Yat-Sen University
  • First Hospital of China Medical University
  • Fujian Medical University Union Hospital
  • General Hospital of Ningxia Medical University
  • Guangzhou Red Cross Hospital
  • Guilin Medical University, China
  • Guizhou Provincial People's Hospital
  • Huashan Hospital
  • Inner Mongolia People's Hospital
  • Jiangnan University Medical Center
  • Lanzhou University Second Hospital
  • Nanfang Hospital, Southern Medical University
  • National Center for Neurological Disorders (China)
  • Peking University First Hospital
  • Peking University Third Hospital
  • Qilu Hospital of Shandong University
  • Qilu Hospital of Shandong University (Qingdao)
  • Qingdao Municipal Hospital
  • Qinghai People's Hospital
  • RenJi Hospital
  • Ruijin Hospital
  • Second Affiliated Hospital of Nanchang University
  • Second Affiliated Hospital of Soochow University
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Second People's Hospital of Tibet Autonomous Region
  • Second Xiangya Hospital of Central South University
  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital
  • Shanxi Provincial People's Hospital
  • Shengjing Hospital
  • Shenzhen Second People's Hospital
  • Sichuan Academy of Medical Sciences
  • Sichuan Provincial People's Hospital
  • Tangshan Gongren Hospital
  • The Affiliated Hospital Of Guizhou Medical University
  • The Affiliated Hospital of Xuzhou Medical University
  • The First Affiliated Hospital of Anhui Medical University
  • The First Affiliated Hospital of Guangzhou Medical University
  • The First Affiliated Hospital of Shanxi Medical University
  • The First Affiliated Hospital of Soochow University
  • The First Affiliated Hospital of Xiamen University
  • The First Affiliated Hospital of Zhengzhou University
  • The First Dongguan Affiliated Hospital of Guangdong Medical University
  • The First Hospital of Jilin University
  • The General Hospital of Eastern Theater Command
  • The General Hospital of Northern Theater Command
  • The Second Affiliated Hospital of Dalian Medical University
  • The Second Affiliated Hospital of Hainan Medical University
  • The Second Affiliated Hospital of Kunming Medical University
  • The Second Hospital of Hebei Medical University
  • The Southwest Hospital of Army Medical University
  • The second People's Hospital of Guiyang
  • Tianjin Huanhu Hospital
  • Tianjin Medical University General Hospital
  • Tibet Autonomous Region People's Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • West China Hospital
  • Wuhan TongJi Hospital
  • Xijing hospital of The fourth military medical university
  • Xuanwu Hospital, Beijing
  • Xunxian People's Hospital
  • Zhejiang University

Registry information

Acronym: ChTUIA

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 6, 2023
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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