Clinical Trail of Hybrid Operating Technique in Management of Complex Intracranial Aneurysms With Coexistence of Multiple Risk Factors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intracranial Aneurysm
- Sponsor
- liuxingju
- Enrollment
- 258
- Locations
- 1
- Primary Endpoint
- operation-related mortality rate
- Last Updated
- 8 years ago
Overview
Brief Summary
To evaluate the clinical benefits and risks of hybrid operating techniques in management of complex intracranial aneurysms, which could coexists with multiple risk factors.
Detailed Description
Purpose: Have an evaluation of clinical benefits and risks of hybrid operating techniques in management of complex intracranial aneurysms (CIAs), which could coexists with multiple risk factors. Meanwhile, as a new cooperative interventional modality, optimized workflows, technical key knots and operation routines will be explored in the study. Objects: Patients with CIAs, coincident with inclusion and exclusion criterion and admitted in participating organizations. Methods: Patients will be distributed into 2 groups, including traditional therapy group(control group) and hybrid operating group(trial group), and conduct with traditional neurosurgical management or one-stage hybrid operating management correspondingly. Peri-operative mortality rate is considered to be the primary observing indicator, and morbidity rate of peri-operative cerebral hemorrhagic/ischemic event, morbidity rate of aneurysmal residuals, morbidity rate of neural functional deteriorations, and health-economic indicators are secondary indicators.The information of operations will be recorded in detail as evidence of optimization of workflow and technical key knots.
Investigators
liuxingju
Researcher
Ministry of Science and Technology of the People´s Republic of China
Eligibility Criteria
Inclusion Criteria
- •with diagnosed complex intracranial aneurysm by digital subtraction angiography(DSA);
- •got SAH in history;
- •neural functional deficits due to aneurysms;
- •with \<4 in Hunt-Hess Grades;
- •≥5.0mm in the maximum diameter;
- •\<70 years old;
- •with irregular morphological features and high rupture risk.
Exclusion Criteria
- •\>70 in age, with low rupture risk;
- •cannot tolerant the operation;
- •patient or relative refuses to participate the trail;
- •SAH patient with ≥4 Hunt-Hess grading system;
- •\<5.0mm in the maximum diameter.
Outcomes
Primary Outcomes
operation-related mortality rate
Time Frame: From the time of operation begin to 48 hours after operation
the mortality rate related to the operation
Secondary Outcomes
- Morbidity rate of peri-operative intracranial ischemic events(From date of admission to 7 days after operation)
- Residual rate of aneurysms(the date of first post-operative cerebrovascular angiography is conducted, up to 3 months after operation)
- Morbidity rate of neural functional deterioration in 48 hours after operation(48 hours after operation, ±6 hours)
- Duration of total operating time(through study completion, an average of 1 year)
- Morbidity rate of peri-operative intracranial hemorrhage(From date of admission to the 7 days after operation)
- Morbidity rate of neural functional deterioration in 12 months(the 12th month after operation, ±1 week)
- Treatment-related costs(through study completion, an average of 1 year)
- Duration of hospitalization(through study completion, an average of 1 year)
- Morbidity rate of neural functional deterioration in 7 days(7 days after operation, ±2 days)
- Morbidity rate of neural functional deterioration in 3 months(the 3rd month after operation, ±1 week)
- Morbidity rate of neural functional deterioration in 6 months(the 6th month after operation, ±1 week)