Treatment Strategies for Unruptured Intracranial Aneurysms in the Chinese Population China Treatment Trial for Unruptured Intracranial Aneurysm (ChTUIA)
- Conditions
- Unruptured Intracranial Aneurysm
- Interventions
- Other: observation
- Registration Number
- NCT05844163
- Lead Sponsor
- Beijing Tiantan Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31595
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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Conservative treatment group observation Patients in conservative treatment group receive optimal drug therapy including appropriate blood pressure control and other measures. Flow diversion group. observation Patients in flow diversion group receive flow diverters. Coil embolization or stent-assisted coil embolization group observation Patients in coil embolization or stent-assisted coil embolization group receive coil embolization or stent-assisted coil embolization according to individualized condition. Intracranial aneurysm clipping group observation Patients in Intracranial aneurysm clipping group receive neurosurgical clipping.
- Primary Outcome Measures
Name Time Method Primary Outcome 2 years Functional outcomes(modified Rankin Scale,mRS) at 2 years after treatment decision
- Secondary Outcome Measures
Name Time Method Cost 2 years Costs associated with unruptured intracranial aneurysms within 2 years after treatment with different strategies.
Aneurysm-related bleeding events 2 years Incidence of aneurysmal-related bleeding events within 2 years after receiving different treatment strategies.
Mortality associated with intracranial aneurysms 2 years Mortality associated with intracranial aneurysms within 2 years after treatment with different strategies
MACCE events 1 years Incidence of major adverse cardiovascular/cerebrovascular events (MACCE events) in patients with atherosclerotic heart disease within 1 year after treatment decision.
cardiovascular/cerebrovascular events 2 years Incidence of cardiovascular/cerebrovascular events in 2 years after receiving different treatment strategies.
All-cause mortality 2 years All-cause mortality of patients within 2 years after different treatment strategies.
Trial Locations
- Locations (1)
Capital Medical University Affiliated Beijing Tiantan Hospital
🇨🇳Beijing, Beijing, China