To evaluate the clinical benefits and risks of hybrid operating techniques in management of intracranial aneurysms with coexistence of atherosclerotic intracranial arterial stenosis.
Purpose: Have an evaluation of clinical benefits and risks of hybrid operating techniques in management of intracranial aneurysms (IAs) with coexistence of atherosclerotic intracranial arterial stenosis (AIAS), whose management strategies are inconsistent. Meanwhile, as a new cooperative interventional modality, optimized workflows, technical key knots and operation routines will be explored in the study. Objects: Patients with IAs with coexistence of AIAS, 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 multi-stage neurosurgical management or one-stage hybrid operating management correspondingly. The morbidity rate of peri-operative cerebral hemorrhagic/ischemic event is considered to be the primary observing indicator, and morbidity rate of peri-operative cerebral hemorrhagic/ischemic event, while peri-operative mortality rate, 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
196
The microsurgical techniques used to evacuate the aneurysm out of circulation or reduce its risk of rupture by aneurysmal clipping, wrapping,or isolation.
The endovascular techniques that recanalize the narrowed or occluded cerebrovascular, including stent implantation, balloon dilatation.
The endovascular techniques that embolize the cavity of aneurysms to reduce the risk of rupture, including coiling embolization, balloon-assisted occlusion.
Beijing Tiantan Hospital Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGmorbidity rate of peri-operative cerebral hemorrhagic events
the morbidity rate of cerebral hemorrhagic events, with significant neuro-image evidence, during the period of treatment, including SAH/ICH/IVH caused by IAs, and intracranial hemorrhages caused by interventions focusing on AIAS
Time frame: through study completion, an average of 1 year
morbidity rate of peri-operative cerebral ischemic events
the morbidity rate of cerebral ischemic events, with significant neuro-image evidence, during the period of treatment, including all cerebral infarctions caused by interventions focusing on IAs and AIAS.
Time frame: through study completion, an average of 1 year
Peri-operative mortality rate
The mortality rate during the period of treatment
Time frame: through study completion, an average of 1 year
Treatment-related costs
The total in-patient expenses of the aiming diseases, covering all treating stages
Time frame: through study completion, an average of 1 year
Duration of hospitalization
The total hospitalizations for the treatment of aiming diseases, covering all treating stages
Time frame: through study completion, an average of 1 year
Duration of total operating time
The total operating time, the sum of durations of multi-stages operation if several procedures are presented
Time frame: through study completion, an average of 1 year
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A microsurgical technique to recanalize the stenosis or occluded proximal segment of carotid artery.