Surgical Management of Complex Intracranial Aneurysms With Hybrid Operating Techniques

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical Trail of Hybrid Operating Technique in Management of Complex Intracranial Aneurysms With Coexistence of Multiple Risk Factors

Conditions
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Intracranial Aneurysm

Intervention / Treatment
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* Procedure: Hybrid Operating Techniques


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hybrid operation group<br>Intervene with hybrid operating techniques, eg. microsurgical clipping+endovascular coiling or with the assistant of balloon occlusion. | Procedure: Hybrid Operating Techniques<br>* 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.<br>* Other names: flow diverter;|
| Other: Traditional therapy group<br>The aneurysms will be executed by traditional procedure, including microsurgical clipping, endovascular coiling or stenting, etc. | Procedure: Hybrid Operating Techniques<br>* 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.<br>* Other names: flow diverter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operation-related mortality rate | the mortality rate related to the operation | From the time of operation begin to 48 hours after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity rate of peri-operative intracranial hemorrhage | 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. | From date of admission to the 7 days after operation | 
| Morbidity rate of peri-operative intracranial ischemic events | The intracranial ischemic events happening during the peri-operative period, including operation-related infarction, embolization, etc. With neuro-imaging evidence. | From date of admission to 7 days after operation | 
| Residual rate of aneurysms | the morbidity rate of aneurysmal residue, with post-operative DSA/CTA evidence | 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 | The score of modified Rankin Scale increases ≥2, comparing to the original mRS scores | 48 hours after operation, ±6 hours | 
| Morbidity rate of neural functional deterioration in 7 days | The score of modified Rankin Scale increases ≥2, comparing to the original mRS scores | 7 days after operation, ±2 days | 
| Morbidity rate of neural functional deterioration in 3 months | The score of modified Rankin Scale increases ≥2, comparing to the original mRS scores | the 3rd month after operation, ±1 week | 
| Morbidity rate of neural functional deterioration in 6 months | The score of modified Rankin Scale increases ≥2, comparing to the original mRS scores | the 6th month after operation, ±1 week | 
| Morbidity rate of neural functional deterioration in 12 months | The score of modified Rankin Scale increases ≥2, comparing to the original mRS scores | the 12th month after operation, ±1 week | 
| Treatment-related costs | All expenses cost in hospital relating to the aiming disease | through study completion, an average of 1 year | 
| Duration of hospitalization | Total hospitalization of all stages of treatments to IAs, including admissions for evaluation, operation, and DSA | through study completion, an average of 1 year | 
| Duration of total operating time | Total operating time of all procedures, including operation, and DSA | through study completion, an average of 1 year |