Hybrid Operating Treatment of Coexistence of Intracranial Aneurysms and Cerebrovascular Stenosis

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 intracranial aneurysms with coexistence of atherosclerotic intracranial arterial stenosis.

Detailed Description
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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.

Official Title
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Clinical Trail of Hybrid Operating Technique in Management of Intracranial Aneurysms With Coexistence of Atherosclerotic Intracranial Arterial Stenosis

Conditions
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Intracranial Aneurysm, Cerebrovascular Stenosis, Atheroscleroses, Cerebral

Intervention / Treatment
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* Procedure: Microsurgical aneurysmal operating techniques
* Procedure: endovascular techniques for cerebrovascular stenosis
* Procedure: endovascular techniques for intracranial aneurysms
* Procedure: carotid endarterectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For aneurysms: 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. and for stenosis Intracranial vessels: >50% in rate of stenosis with ischemic symptoms/perfusing evidence/lacunar infarction in supplying territory, failed in conservative treatment; with a deliverable position of intracranial stents devices. or Vertebral arterial system: ≥70% in the rate of stenosis, with contralateral vertebral arterial occlusion; symptomatic vertebral arterial stenosis, accompanied with posterior inferior cerebellum artery derived from the affected artery and related symptoms are caused/clinical benefits can be achieved through angioplasty. or Extracranial arterial system: ≥70% in the rate of stenosis with symptoms; nonsymptomatic patients, ≥70% in the rate of stenosis , with perfusing evidence. Exclusion Criteria: >70 in age, with low rupture risk; stroke history in 6 weeks (contraindication for endovascular intervention); coexistence with intracranial tumor or AVM; cannot tolerant the operation; patient or relative refuses to participate the trail

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: Patients of intracranial aneurysms with coexistence of cerebrovascular stenosis, coincident with inclusion and exclusion criterion, will be distributed into traditional therapy group(control group) and hybrid operating group(test group), and conduct with traditional neurosurgical management or one-stage hybrid operating management separately. Traditional therapy group: intervene the aneurysms and vascular stenosis unsimultaneously. Clipping procedure is preferred to aneurysms, while endovascular intervention is preferred to stenosis. Hybrid operation group: one-stage hybrid operating technique is conducted. The aneurysms and vascular stenosis will be executed via the cooperation of microsurgical procedure and endovascular interventional techniques.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Traditional therapy<br>Consists of microsurgical aneurysmal operating techniques, endovascular techniques for intracranial aneurysms, endovascular techniques for cerebrovascular stenosis, and carotid endarterectomy, which are presented by stages. | Procedure: Microsurgical aneurysmal operating techniques<br>* The microsurgical techniques used to evacuate the aneurysm out of circulation or reduce its risk of rupture by aneurysmal clipping, wrapping,or isolation.<br>* Other names: microsurgical aneurysmal isolation;Procedure: endovascular techniques for cerebrovascular stenosis<br>* The endovascular techniques that recanalize the narrowed or occluded cerebrovascular, including stent implantation, balloon dilatation.<br>* Other names: endovascular balloon dilatation;Procedure: endovascular techniques for intracranial aneurysms<br>* The endovascular techniques that embolize the cavity of aneurysms to reduce the risk of rupture, including coiling embolization, balloon-assisted occlusion.<br>* Other names: flow diverter;Procedure: carotid endarterectomy<br>* A microsurgical technique to recanalize the stenosis or occluded proximal segment of carotid artery.<br>|
| Experimental: Hybrid operation<br>Consists of microsurgical aneurysmal operating techniques, endovascular techniques for intracranial aneurysms, endovascular techniques for cerebrovascular stenosis, and carotid endarterectomy, which are presented in one-stage in hybrid operating theater. | Procedure: Microsurgical aneurysmal operating techniques<br>* The microsurgical techniques used to evacuate the aneurysm out of circulation or reduce its risk of rupture by aneurysmal clipping, wrapping,or isolation.<br>* Other names: microsurgical aneurysmal isolation;Procedure: endovascular techniques for cerebrovascular stenosis<br>* The endovascular techniques that recanalize the narrowed or occluded cerebrovascular, including stent implantation, balloon dilatation.<br>* Other names: endovascular balloon dilatation;Procedure: endovascular techniques for intracranial aneurysms<br>* The endovascular techniques that embolize the cavity of aneurysms to reduce the risk of rupture, including coiling embolization, balloon-assisted occlusion.<br>* Other names: flow diverter;Procedure: carotid endarterectomy<br>* A microsurgical technique to recanalize the stenosis or occluded proximal segment of carotid artery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morbidity 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 | 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. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-operative mortality rate | The mortality rate during the period of treatment | through study completion, an average of 1 year | 
| Treatment-related costs | The total in-patient expenses of the aiming diseases, covering all treating stages | through study completion, an average of 1 year | 
| Duration of hospitalization | The total hospitalizations for the treatment of aiming diseases, covering all treating stages | 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 | through study completion, an average of 1 year |