Surgical Management of Complex Intracranial Aneurysms With Hybrid Operating Techniques (CIA-HOTs)

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

To evaluate the clinical benefits and risks of hybrid operating techniques in management of complex intracranial aneurysms, which could coexists with multiple risk factors.

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.

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.

Intervene with hybrid operating techniques, eg. microsurgical clipping+endovascular coiling or with the assistant of balloon occlusion.

The aneurysms will be executed by traditional procedure, including microsurgical clipping, endovascular coiling or stenting, etc.

microsurgical clipping, microsurgical dissection, microsurgical wrapping, microsurgical isolation, endovascular coiling, balloon-assisted occlusion, flow diverter

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.

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.

The intracranial ischemic events happening during the peri-operative period, including operation-related infarction, embolization, etc. With neuro-imaging evidence.

the date of first post-operative cerebrovascular angiography is conducted, up to 3 months after operation

Total hospitalization of all stages of treatments to IAs, including admissions for evaluation, operation, and DSA

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.