Clinical Trail of Hybrid Operating Technique in Management of Intracranial Aneurysms With Coexistence of Atherosclerotic Intracranial Arterial Stenosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intracranial Aneurysm
- Sponsor
- liuxingju
- Enrollment
- 196
- Locations
- 1
- Primary Endpoint
- morbidity rate of peri-operative cerebral hemorrhagic events
- Last Updated
- 8 years ago
Overview
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.
Investigators
liuxingju
Researcher
Ministry of Science and Technology of the People´s Republic of China
Eligibility Criteria
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:
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
Outcomes
Primary Outcomes
morbidity rate of peri-operative cerebral hemorrhagic events
Time Frame: 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
Time Frame: 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 Outcomes
- Peri-operative mortality rate(through study completion, an average of 1 year)
- Treatment-related costs(through study completion, an average of 1 year)
- Duration of hospitalization(through study completion, an average of 1 year)
- Duration of total operating time(through study completion, an average of 1 year)