Atheroscleroses, Cerebral, Cerebrovascular Stenosis, Intracranial Aneurysm
Conditions
Brief summary
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
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.
Interventions
PROCEDUREMicrosurgical aneurysmal operating techniques
The microsurgical techniques used to evacuate the aneurysm out of circulation or reduce its risk of rupture by aneurysmal clipping, wrapping,or isolation.
PROCEDUREendovascular techniques for cerebrovascular stenosis
The endovascular techniques that recanalize the narrowed or occluded cerebrovascular, including stent implantation, balloon dilatation.
PROCEDUREendovascular techniques for intracranial aneurysms
The endovascular techniques that embolize the cavity of aneurysms to reduce the risk of rupture, including coiling embolization, balloon-assisted occlusion.
PROCEDUREcarotid endarterectomy
A microsurgical technique to recanalize the stenosis or occluded proximal segment of carotid artery.
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
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| morbidity rate of peri-operative cerebral hemorrhagic events | through study completion, an average of 1 year | 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 |
| morbidity rate of peri-operative cerebral ischemic events | through study completion, an average of 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peri-operative mortality rate | through study completion, an average of 1 year | The mortality rate during the period of treatment |
| Treatment-related costs | through study completion, an average of 1 year | The total in-patient expenses of the aiming diseases, covering all treating stages |
| Duration of hospitalization | through study completion, an average of 1 year | The total hospitalizations for the treatment of aiming diseases, covering all treating stages |
| Duration of total operating time | through study completion, an average of 1 year | The total operating time, the sum of durations of multi-stages operation if several procedures are presented |
Countries
China
Contacts
Primary ContactXingju Liu, MD
Backup ContactMingze Wang, MD
Outcome results
None listed