Intracranial Aneurysm
Conditions
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.
Interventions
PROCEDUREHybrid Operating Techniques
It is a cooperation of existing endovascular interventional techniques and microsurgical techniques. Different from traditional management, hybrid operating techniques make it possible for 2 existing techniques conducting simultaneously in a hybrid operating theater. It optimizes the traditional microsurgical techniques for complex intracranial aneurysms and avoids the transportation of patients and the risks of intervals between stages in traditional ones. It includes balloon-assisted parental arterial occlusion, one-stage aneurysm clipping/wrapping/isolation and embolization/diverter implantation, etc.
Sponsors
Beijing Municipal Science & Technology Commission
liuxingju
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Traditional therapy group：the aneurysms will be executed by traditional procedure, including microsurgical clipping, endovascular coiling or stenting, etc. Hybrid operation group: Intervene with hybrid operating techniques, eg. microsurgical clipping+endovascular coiling or with the assistant of balloon occlusion.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| operation-related mortality rate | From the time of operation begin to 48 hours after operation | the mortality rate related to the operation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity rate of peri-operative intracranial ischemic events | From date of admission to 7 days after operation | The intracranial ischemic events happening during the peri-operative period, including operation-related infarction, embolization, etc. With neuro-imaging evidence. |
| Residual rate of aneurysms | the date of first post-operative cerebrovascular angiography is conducted, up to 3 months after operation | the morbidity rate of aneurysmal residue, with post-operative DSA/CTA evidence |
| Morbidity rate of neural functional deterioration in 48 hours after operation | 48 hours after operation, ±6 hours | The score of modified Rankin Scale increases ≥2, comparing to the original mRS scores |
| Morbidity rate of neural functional deterioration in 7 days | 7 days after operation, ±2 days | The score of modified Rankin Scale increases ≥2, comparing to the original mRS scores |
| Morbidity rate of neural functional deterioration in 3 months | the 3rd month after operation, ±1 week | The score of modified Rankin Scale increases ≥2, comparing to the original mRS scores |
| Morbidity rate of peri-operative intracranial hemorrhage | From date of admission to the 7 days after operation | Intracranial hemorrhagic events happening during the peri-operative period, including subarachnoid hemorrhage, intracranial hemorrhage, intraventricular hemorrhage caused by the rupture of aneurysms with neuro-imaging evidence. |
| Morbidity rate of neural functional deterioration in 12 months | the 12th month after operation, ±1 week | The score of modified Rankin Scale increases ≥2, comparing to the original mRS scores |
| Treatment-related costs | through study completion, an average of 1 year | All expenses cost in hospital relating to the aiming disease |
| Duration of hospitalization | through study completion, an average of 1 year | Total hospitalization of all stages of treatments to IAs, including admissions for evaluation, operation, and DSA |
| Duration of total operating time | through study completion, an average of 1 year | Total operating time of all procedures, including operation, and DSA |
| Morbidity rate of neural functional deterioration in 6 months | the 6th month after operation, ±1 week | The score of modified Rankin Scale increases ≥2, comparing to the original mRS scores |
Countries
China
Contacts
Primary ContactXingju Liu, MD
Backup ContactMingze Wang, MD
Outcome results
None listed